FDA
Food & drug recalls
Recalls of food, drugs, and devices: what, who, why, and where it was sent.
Published by FDA
Finest detail facility
Tables 1
Recalls
Sample of 25 rows out of about 79,040
· 29 columns
| id | recall_number | center | product_type | event_id | status | classification | voluntary_mandated | recalling_firm | firm_kind | address_1 | address_2 | city | state | postal_code | country | recall_initiation_date | center_classification_date | report_date | termination_date | initial_firm_notification | distribution_pattern | product_description | product_quantity | reason_for_recall | code_info | more_code_info | openfda | export_date |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | D-0023-2027 | drug | Drugs | 99867 | Ongoing | Class II | Voluntary: Firm initiated | Carolina Infusion, LLC | other | 95 Bees Creek Rd | N/A | Ridgeland | SC | 29936-7540 | United States | 2026-09-10 | 2026-10-08 | 2026-10-14 | No data | Nationwide within the U.S | Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936, | 5 mL in patient specific syringe doses | Lack of Assurance of Sterility: Related to processing equipment used in compounded product. | Lot: 07242026@7, BUD: 09/7/2026. | No data | {} | 2026-10-27 | |
| 2 | D-0038-2027 | drug | Drugs | 100013 | Ongoing | Class II | Voluntary: Firm initiated | Teva Pharmaceuticals USA, Inc | other | 400 Interpace Pkwy Bldg A | Parsippany | NJ | 07054-1120 | United States | 2026-09-29 | 2026-10-13 | 2026-10-21 | No data | Letter | US Nationwide. | Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC 100 Tablets: 0093-2204-01; NDC 500 Tablets: 0093-2204-05 | 240,448 cartons | Presence of Foreign Tablets/Capsules | Lot, expiry: [100 Tablets] Lots 8634085, 8635085, 8636085, exp 07/2027; [500 Tablets] Lot 8633085, exp 07/2027 | {"application_number": ["ANDA070184"], "brand_name": ["METOCLOPRAMIDE"], "generic_name": ["METOCLOPRAMIDE"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "product_ndc": ["0093-2203", "0093-2204"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["ORAL"], "substance_name": ["METOCLOPRAMIDE HYDROCHLORIDE"], "rxcui": ["311666", "311668"], "spl_id": ["61b5d2d5-1e7b-44ff-a831-1a0de78edecd"], "spl_set_id": ["e15905e0-e0f6-4c8b-ac19-59724d6c4bf0"], "package_ndc": ["0093-2204-01", "0093-2204-05", "0093-2203-01", "0093-2203-05", "0093-2203-10"], "is_original_packager": [true], "upc": ["0300932203013", "0300932204010"], "unii": ["W1792A2RVD"]} | 2026-10-27 | ||
| 3 | D-0025-2027 | drug | Drugs | 99867 | Ongoing | Class II | Voluntary: Firm initiated | Carolina Infusion, LLC | other | 95 Bees Creek Rd | N/A | Ridgeland | SC | 29936-7540 | United States | 2026-09-10 | 2026-10-08 | 2026-10-14 | No data | Nationwide within the U.S | Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 | 5 mL in patient specific syringe dose | Lack of Assurance of Sterility: Related to processing equipment used in compounded product. | Lot:08062026@10, BUD: 9/20/2026. | No data | {} | 2026-10-27 | |
| 4 | D-0021-2027 | drug | Drugs | 99867 | Ongoing | Class II | Voluntary: Firm initiated | Carolina Infusion, LLC | other | 95 Bees Creek Rd | N/A | Ridgeland | SC | 29936-7540 | United States | 2026-09-10 | 2026-10-08 | 2026-10-14 | No data | Nationwide within the U.S | QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 | 5 mls in patient specific syringe doses | Lack of Assurance of Sterility: Related to processing equipment used in compounded product. | LOT: 08032026@24, BUD: 09/17/2026. | No data | {} | 2026-10-27 | |
| 5 | D-0014-2027 | drug | Drugs | 99930 | Ongoing | Class II | Voluntary: Firm initiated | Cipla USA, Inc. | other | 10 Independence Blvd | N/A | Warren | NJ | 07059-2730 | United States | 2026-09-18 | 2026-10-06 | 2026-10-14 | No data | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit | USA Nationwide. | Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-579-67. | N/A | Failed Impurities/Degradation Specifications | Lot#: 5KA0405, Exp 12/31/2026. | No data | {"application_number": ["ANDA211881"], "brand_name": ["FOSFOMYCIN TROMETHAMINE"], "generic_name": ["FOSFOMYCIN TROMETHAMINE"], "manufacturer_name": ["Cipla USA Inc."], "product_ndc": ["69097-579"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["ORAL"], "substance_name": ["FOSFOMYCIN TROMETHAMINE"], "rxcui": ["808917"], "spl_id": ["80c866f4-c984-469e-b2a5-5c23f29b9750"], "spl_set_id": ["d101b5d8-bffc-4ee6-b93b-4589fcb8750d"], "package_ndc": ["69097-579-67"], "is_original_packager": [true], "unii": ["7FXW6U30GY"]} | 2026-10-27 |
| 6 | D-0041-2027 | drug | Drugs | 99990 | Ongoing | Class II | Voluntary: Firm initiated | Houston Rx LLC | pharmacy | 15340 Vantage Pkwy E Ste 220 | Houston | TX | 77032-1901 | United States | 2026-09-25 | 2026-10-13 | 2026-10-21 | No data | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit | Nationwide in the USA. | Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032. | 7 vials | Lack of process control | Lot# SER-081726-1-10, Beyond Use Date: 10/01/2026. | {} | 2026-10-27 | ||
| 7 | D-0024-2027 | drug | Drugs | 99867 | Ongoing | Class II | Voluntary: Firm initiated | Carolina Infusion, LLC | other | 95 Bees Creek Rd | N/A | Ridgeland | SC | 29936-7540 | United States | 2026-09-10 | 2026-10-08 | 2026-10-14 | No data | Nationwide within the U.S | Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 | 3 ML in patient specific syringe dose | Lack of Assurance of Sterility: Related to processing equipment used in compounded product. | Lot:08042026@8, BUD: 9/18/2026. | No data | {} | 2026-10-27 | |
| 8 | D-0013-2027 | drug | Drugs | 99994 | Ongoing | Class II | Voluntary: Firm initiated | Preferred Pharmaceuticals, Inc. | other | 1250 N Lakeview Ave Ste O | N/A | Anaheim | CA | 92807-1801 | United States | 2026-09-28 | 2026-10-06 | 2026-10-14 | No data | USA Nationwide | Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A., Inc., Prod# (NDC): 68788-7865-05 | N/A | Failed Content Uniformity Specifications | Lot #: F1925G, Expiry: 4/30/2027; Lot #: E0925T, Expiry: 4/30/2027; Lot # D3025M, Expiry: 4/30/2027; Lot #: D0825D, Expiry: 4/30/2027. | No data | {} | 2026-10-27 | |
| 9 | D-0027-2027 | drug | Drugs | 99867 | Ongoing | Class II | Voluntary: Firm initiated | Carolina Infusion, LLC | other | 95 Bees Creek Rd | N/A | Ridgeland | SC | 29936-7540 | United States | 2026-09-10 | 2026-10-08 | 2026-10-14 | No data | Nationwide within the U.S | TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 | 297 mL - in patient specific syringe dose | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. | Lot:07212026@18, BUD: 9/4/2026; 07222026@14, BUD: 9/5/2026; 07292026@8, BUD: 9/12/2026; 08052026@14, BUD: 9/19/2026; 08142026@1, BUD: 9/28/2026; 08192026@10, BUD: 10/3/2026; 08242026@25, BUD: 10/8/2026; 08282026@2, BUD: 10/12/2026; 08292026@1, BUD:10/13/2026; | No data | {} | 2026-10-27 | |
| 10 | D-0004-2027 | drug | Drugs | 99880 | Ongoing | Class II | Voluntary: Firm initiated | K.C. Pharmaceuticals, Inc. | other | 3420 Pomona Blvd | N/A | Pomona | CA | 91768-3236 | United States | 2026-09-11 | 2026-10-05 | 2026-10-14 | No data | US Nationwide | Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0456-1; b) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25392 6; c) GoodSense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; d) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43745 0; e) Medic'c Choice, Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-025-01; f) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, NDC 70677-1158-1; g) Colirio Manzanill A+, Distributed by: PRO-MEX, P.O Box 63-0716, Miami , FL 33163, UPC: 1 84125 00018 0; h) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 06776 9; I) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; J) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3. | 208,896 cartons | Lack of Assurance of Sterility | Lot: a) AR25A02, Exp.: 1/1/2027; b) AR25A02, Exp.: 1/1/2027; c) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; d) AR25A02, Exp.: 1/1/2027; e) AR25A02, Exp.: 1/1/2027; f) AR25A02, Exp.: 1/1/2027; g) AR25F01, Exp.: 6/30/2027; AR25N01, Exp.: 11/30/2027; h) AR25A02, Exp.: 1/1/2027; I) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; J) AR25A01, Exp.: 1/1/2027. | No data | {"application_number": ["M018"], "brand_name": ["LEADER ADVANCED RELIEF EYE DROPS", "GOODSENSE EYE DROPS ADVANCED RELIEF MOISTURIZER", "MEDICS CHOICE EYE DROPS ADVANCED", "FOSTER AND THRIVE ADVANCED RELIEF EYE DROPS", "QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS"], "generic_name": ["DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL", "DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL", "TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE", "POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL"], "manufacturer_name": ["Cardinal Health", "Geiss, Derstin & Dunn, Inc.", "KC Pharmaceuticals, Inc.", "Strategic Sourcing Services LLC", "Chain Drug Marketing Association, Inc."], "product_ndc": ["70000-0456", "50804-130", "55651-025", "70677-1158", "83324-191"], "product_type": ["HUMAN OTC DRUG"], "route": ["OPHTHALMIC"], "substance_name": ["DEXTRAN 70", "POLYETHYLENE GLYCOL 400", "POVIDONE", "TETRAHYDROZOLINE HYDROCHLORIDE"], "rxcui": ["996202", "996209"], "spl_id": ["4ccce313-8eec-8a62-e063-6394a90aa128", "47450d1c-db32-92cd-e063-6394a90a0703", "4748d5b2-f2f1-e88b-e063-6394a90af39a", "474922b2-773c-4cff-e063-6394a90a6b3a", "4749597d-57d8-92b6-e063-6294a90ab574"], "spl_set_id": ["5c5d6c13-9b51-48f0-8627-b60b0f707fd3", "9b34de99-13df-201a-e053-2a95a90ae559", "ab906fd8-265c-4359-a920-d626366e245c", "0019cd99-b245-2ffc-e063-6294a90a9f27", "1fb81759-5931-59c8-e063-6294a90a2277"], "package_ndc": ["70000-0456-1", "50804-130-01", "55651-025-01", "70677-1158-1", "83324-191-14"], "is_original_packager": [true], "upc": ["0096295136470", "0180410000194", "0095072012518", "0010939958273", "0635515903760", "041163253926", "041220437450", "184125000180", "041415067769", "036800036413"], "nui": ["N0000184175", "N0000009361", "N0000010288"], "pharm_class_epc": ["Plasma Volume Expander [EPC]"], "pharm_class_pe": ["Increased Intravascular Volume [PE]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "unii": ["7SA290YK68", "B697894SGQ", "FZ989GH94E", "0YZT43HS7D"]} | 2026-10-27 | |
| 11 | D-0028-2027 | drug | Drugs | 99867 | Ongoing | Class II | Voluntary: Firm initiated | Carolina Infusion, LLC | other | 95 Bees Creek Rd | N/A | Ridgeland | SC | 29936-7540 | United States | 2026-09-10 | 2026-10-08 | 2026-10-14 | No data | Nationwide within the U.S | TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 | 29.6 mls - in patient specific syringe dose | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. | Lot:07252026@3, BUD: 9/8/2026; 08112026@5, BUD: 9/25/2026; 08212026@21, BUD: 10/5/2026; 08282026@3, BUD: 10/12/2026. | No data | {} | 2026-10-27 | |
| 12 | D-0006-2027 | drug | Drugs | 99880 | Ongoing | Class II | Voluntary: Firm initiated | K.C. Pharmaceuticals, Inc. | other | 3420 Pomona Blvd | N/A | Pomona | CA | 91768-3236 | United States | 2026-09-11 | 2026-10-05 | 2026-10-14 | No data | US Nationwide | Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; b) Crocodile Tears, Distributed by: Crocodile Tears, Palm Beach Gardens, FL 33410, UPC: 8 67166 00000 4; c) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC: 0 93351 01156 6; d) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 14299 05620 6; e) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., 1295 Towbin Ave., Lakewood, NJ 08701, NDC 57896-181-05; f) H.E.B Dry Eye, Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 71303 2; h) Foster & Thrive, Distributed by: McKesson Corp. Via Strategic Sourcing Servies LLC., Memphis, TN 38141, NDC 70677-1157-1; I) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3. | 1,327,248 cartons | Lack of Assurance of Sterility | Lot: a) LT25B01, Exp.: 02/28/2027; b) LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; c) LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; d) LT25D02, Exp.: 04/30/2027; LT25M02, Exp.: 10/31/2027; e) LT25B01, Exp.: 02/28/2027; LT25D01, Exp.: 04/30/2027; LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; LT25M01, Exp.: 10/31/2027; LT25M02, Exp.: 10/31/2027; LT25N01, Exp.: 11/30/2027; LT25N02, Exp.: 11/30/2027; f) LT25B01, Exp.: 02/28/2027; g) LT25M02, Exp.: 10/31/2027; h) LT25B01, Exp.: 02/28/2027; I) LT25B01, Exp.: 02/28/2027; LT25D02, Exp.: 04/30/2027; LT25M02, Exp.: 10/31/2027. | No data | {"application_number": ["M018"], "brand_name": ["LEADER DRY EYE RELIEF EYE DROPS", "ARTIFICIAL TEARS", "FOSTER AND THRIVE DRY EYE RELIEF"], "generic_name": ["GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400", "GLYCERIN", "POLYETHYLENE GLYCOL 400"], "manufacturer_name": ["CARDINAL HEALTH 110, LLC. DBA LEADER", "Geri-Care Pharmaceuticals, Corp", "Strategic Sourcing Services LLC"], "product_ndc": ["70000-0502", "57896-181", "70677-1157"], "product_type": ["HUMAN OTC DRUG"], "route": ["OPHTHALMIC"], "substance_name": ["GLYCERIN", "HYPROMELLOSE, UNSPECIFIED", "POLYETHYLENE GLYCOL 400", "HYPROMELLOSES"], "rxcui": ["259581", "2360899"], "spl_id": ["5944f7bf-c84b-497f-e063-6394a90aed1f", "472b069b-4e80-8cb8-e063-6294a90a302b", "4749275b-6982-4eaf-e063-6394a90aaee9"], "spl_set_id": ["2ded4bda-b3c3-4521-8701-5c8446fd148b", "7cc437e3-bad9-59be-e053-2991aa0a1da3", "0018ade9-5856-db6c-e063-6394a90a2ccf"], "package_ndc": ["70000-0502-1", "70000-0502-2", "57896-181-05", "70677-1157-1"], "is_original_packager": [true], "upc": ["0096295137064", "0096295137071", "0357896184056", "0010939958266", "867166000004", "093351011566", "614299056206", "041220437412", "072036713032", "036800361003"], "nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "pharm_class_epc": ["Non-Standardized Chemical Allergen [EPC]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_cs": ["Allergens [CS]", "Glycerol [CS]"], "unii": ["PDC6A3C0OX", "3NXW29V3WO", "B697894SGQ"]} | 2026-10-27 | |
| 13 | D-0042-2027 | drug | Drugs | 100100 | Ongoing | Class II | Voluntary: Firm initiated | American Health Packaging | other | 2550 John Glenn Ave Ste A | Columbus | OH | 43217-1188 | United States | 2026-10-06 | 2026-10-14 | 2026-10-21 | No data | Letter | US Nationwide | Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-620-01; NDC Unit Dose: 60687-620-11 | 5,363 cartons | Presence of Foreign Tablets/Capsules | Lot 1028135, 1029555; Exp. Date 07/31/2027 | {"application_number": ["ANDA072801"], "brand_name": ["METOCLOPRAMIDE"], "generic_name": ["METOCLOPRAMIDE"], "manufacturer_name": ["American Health Packaging"], "product_ndc": ["60687-620", "60687-631"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["ORAL"], "substance_name": ["METOCLOPRAMIDE HYDROCHLORIDE"], "rxcui": ["311666", "311668"], "spl_id": ["223f574d-b64f-236d-e063-6294a90aada1"], "spl_set_id": ["998f1782-bbfa-469b-9fe1-c612e8588f70"], "package_ndc": ["60687-620-11", "60687-620-01", "60687-631-11", "60687-631-01"], "original_packager_product_ndc": ["0093-2204", "0093-2203"], "unii": ["W1792A2RVD"]} | 2026-10-27 | ||
| 14 | D-0017-2027 | drug | Drugs | 99867 | Ongoing | Class II | Voluntary: Firm initiated | Carolina Infusion, LLC | other | 95 Bees Creek Rd | N/A | Ridgeland | SC | 29936-7540 | United States | 2026-09-10 | 2026-10-08 | 2026-10-14 | No data | Nationwide within the U.S | TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936; | 5.6 mLs - in patient specific syringe doses | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. | Lots: 09012026@3, BUD: 10/16/2026; 08032026@16, BUD: 9/17/2026; 08052026@8, BUD: 9/19/2026; 08072026@13, BUD: 9/21/2026. | No data | {} | 2026-10-27 | |
| 15 | D-0030-2027 | drug | Drugs | 99867 | Ongoing | Class II | Voluntary: Firm initiated | Carolina Infusion, LLC | other | 95 Bees Creek Rd | N/A | Ridgeland | SC | 29936-7540 | United States | 2026-09-10 | 2026-10-08 | 2026-10-14 | No data | Nationwide within the U.S | TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936; | 30.4 mLs - in patient specific syringe dose | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. | Lot:07212026@9, BUD: 9/4/2026; 07252026@2, BUD: 9/8/2026; 08122026@14, BUD: 9/26/2026; 08272026@8, BUD: 10/11/2026; 08312026@18, BUD: 10/15/2026. | No data | {} | 2026-10-27 | |
| 16 | D-0026-2027 | drug | Drugs | 99867 | Ongoing | Class II | Voluntary: Firm initiated | Carolina Infusion, LLC | other | 95 Bees Creek Rd | N/A | Ridgeland | SC | 29936-7540 | United States | 2026-09-10 | 2026-10-08 | 2026-10-14 | No data | Nationwide within the U.S | SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 | 82.9 mls - in patient specific syringe dose | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. | Lot: 07242026@1, BUD: 9/7/2026; 08032026@20, BUD: 9/17/2026; 08312026@16, BUD: 10/15/2026; 08242026@28, BUD: 10/8/2026; 08072026@16, BUD: 9/21/2026. . | No data | {} | 2026-10-27 | |
| 17 | D-0033-2027 | drug | Drugs | 99977 | Ongoing | Class III | Voluntary: Firm initiated | SUN PHARMACEUTICAL INDUSTRIES INC | other | 2 Independence Way | N/A | Princeton | NJ | 08540-6620 | United States | 2026-09-25 | 2026-10-08 | 2026-10-14 | No data | Letter | US Nationwide. | Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9. | N/A | Failed Impurities/Degradation Specifications | Lot # AD96184, Exp Date: 12/31/2026. | No data | {"application_number": ["ANDA211644"], "brand_name": ["TRETINOIN"], "generic_name": ["TRETINOIN"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "product_ndc": ["51672-1394"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["TOPICAL"], "substance_name": ["TRETINOIN"], "rxcui": ["106303"], "spl_id": ["38ef297e-e4cb-0593-e063-6294a90a324d"], "spl_set_id": ["2b0c8ee4-83a5-48f1-809a-9716131f7290"], "package_ndc": ["51672-1394-0", "51672-1394-9"], "is_original_packager": [true], "nui": ["N0000175607", "M0018962"], "pharm_class_epc": ["Retinoid [EPC]"], "pharm_class_cs": ["Retinoids [CS]"], "unii": ["5688UTC01R"]} | 2026-10-27 |
| 18 | D-0016-2027 | drug | Drugs | 99972 | Ongoing | Class II | Voluntary: Firm initiated | J&J INNOVATIVE MEDICINE | other | 200 Great Valley Pkwy | N/A | Malvern | PA | 19355-1307 | United States | 2026-09-23 | 2026-10-08 | 2026-10-14 | No data | Letter | OH | IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044. NDC: 57894-800-01 | 49 vials | Presence of particulate matter. | Lot JNYJ1208; Exp. 10/30/2027 | No data | {"application_number": ["BLA761430"], "brand_name": ["IMAAVY"], "generic_name": ["NIPOCALIMAB-AAHU"], "manufacturer_name": ["Janssen Biotech, Inc."], "product_ndc": ["57894-800", "57894-801"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["INTRAVENOUS"], "substance_name": ["NIPOCALIMAB"], "rxcui": ["2712699", "2712706", "2712708", "2712709"], "spl_id": ["38376edc-230b-4b2b-8bb6-55b9dccea7a5"], "spl_set_id": ["8886274c-f2b2-48af-85c1-2f90bfe304b8"], "package_ndc": ["57894-801-01", "57894-800-01"], "is_original_packager": [true], "unii": ["87M90CV8NC"]} | 2026-10-27 |
| 19 | D-0022-2027 | drug | Drugs | 99867 | Ongoing | Class II | Voluntary: Firm initiated | Carolina Infusion, LLC | other | 95 Bees Creek Rd | N/A | Ridgeland | SC | 29936-7540 | United States | 2026-09-10 | 2026-10-08 | 2026-10-14 | No data | Nationwide within the U.S | Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936, | 15 mLs - in patient specific syringe doses | Lack of Assurance of Sterility: Related to processing equipment used in compounded product. | Lot: 08072026@2, BUD:9/21/2026; 08032026@10, BUD:09/17/2026. | No data | {} | 2026-10-27 | |
| 20 | D-0039-2027 | drug | Drugs | 100017 | Ongoing | Class II | Voluntary: Firm initiated | Zydus Pharmaceuticals (USA) Inc | other | 73 Route 31 N | Pennington | NJ | 08534-3601 | United States | 2026-10-01 | 2026-10-13 | 2026-10-21 | No data | Letter | Nationwide within the United States | Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1907-1. | 70776 vials | Failed Impurities/Degradation Specifications. | Lot #: LB00047A, LB00048A, Exp. Date 03/2028 | {"application_number": ["ANDA217191"], "brand_name": ["HYDROCORTISONE SODIUM SUCCINATE"], "generic_name": ["HYDROCORTISONE SODIUM SUCCINATE"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "product_ndc": ["70710-1907"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["INTRAMUSCULAR", "INTRAVENOUS"], "substance_name": ["HYDROCORTISONE SODIUM SUCCINATE"], "rxcui": ["238755"], "spl_id": ["9e47e808-7310-4c61-ac62-595a5c357123"], "spl_set_id": ["37534164-9de5-4bb3-9f87-341dfcf90883"], "package_ndc": ["70710-1907-1"], "is_original_packager": [true], "unii": ["50LQB69S1Z"]} | 2026-10-27 | ||
| 21 | D-0002-2027 | drug | Drugs | 99880 | Ongoing | Class II | Voluntary: Firm initiated | K.C. Pharmaceuticals, Inc. | other | 3420 Pomona Blvd | N/A | Pomona | CA | 91768-3236 | United States | 2026-09-11 | 2026-10-05 | 2026-10-14 | No data | US Nationwide | Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47008 3; b) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428, NDC 24385-006-05; d) Good Sense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-110-01; e) Medic'c Choice, Sterile 0.5 fl. oz. (15 mL), Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-008-01; f) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; g) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; I) Walgreens, DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015, UPC 3 11917 06503 8; J) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7. | 505,896 cartons | Lack of Assurance of Sterility | Lot: a) AT25B01, Exp.: 2/28/2027; b) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25F02, Exp.: 6/30/2027; AT25K02, Exp.: 9/30/2027; c) AT25D01, Exp.: 04/30/27; AT25K02, Exp.: 9/30/2027; d) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25F02, Exp.: 6/30/2027; AT25K01, Exp.: 9/30/2027; AT25K02, Exp.: 9/30/2027; e) AT25B01, Exp.: 2/28/2027; f) AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; g) AT25B01, Exp.: 2/28/2027; AT25F02, Exp.: 6/30/2027; AT25K01, Exp.: 9/30/2027; h) AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; I) AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25K02, Exp.: 9/30/2027; J) AT24N01, Exp.: 11/30/2026. | No data | {"application_number": ["M018"], "brand_name": ["LEADER ARTIFICIAL TEARS 15 ML", "GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPS", "GOOD SENSE ARTIFICIAL TEARS", "ARTIFICIAL TEARS", "QUALITY CHOICE ARTIFICIAL TEARS LUBRICANT EYE DROPS"], "generic_name": ["POLYVINYL ALCOHOL, POVIDONE"], "manufacturer_name": ["Cardinal Health", "AmerisourceBergen", "Geiss, Destin & Dunn, Inc.", "KC Pharmaceuticals, Inc.", "Chain Drug Marketing Association, Inc."], "product_ndc": ["70000-0011", "24385-006", "50804-110", "55651-008", "83324-189"], "product_type": ["HUMAN OTC DRUG"], "route": ["OPHTHALMIC"], "substance_name": ["POLYVINYL ALCOHOL, UNSPECIFIED", "POVIDONE", "POVIDONE, UNSPECIFIED", "POLYVINYL ALCOHOL"], "rxcui": ["598050"], "spl_id": ["5b120e34-0a0e-e1ae-e063-6294a90a15bc", "5739a45b-5bf7-5db8-e063-6394a90a7ffc", "47450941-e9fd-623c-e063-6294a90a940b", "4748d0f4-e97c-a0c1-e063-6394a90ac311", "47494778-349f-6448-e063-6294a90a3c34"], "spl_set_id": ["8cccc589-3a8e-baad-e053-2a95a90ab8c7", "ce6852a8-c5e6-403d-a7b4-a2e85d1ebb1f", "9b243301-2e4b-5706-e053-2995a90a9b90", "eb6eb6c4-1609-407b-84e4-c7509811f3c0", "1f669655-4bc7-0175-e063-6294a90a305a"], "package_ndc": ["70000-0011-1", "24385-006-05", "50804-110-01", "55651-008-01", "83324-189-14"], "is_original_packager": [true], "upc": ["0096295137644", "0087701104060", "0180410000163", "0095072015519", "0635515992238", "070038470083", "041415009769", "036800093317", "311917065038", "011110386007"], "unii": ["532B59J990", "FZ989GH94E"]} | 2026-10-27 | |
| 22 | D-0034-2027 | drug | Drugs | 99977 | Ongoing | Class III | Voluntary: Firm initiated | SUN PHARMACEUTICAL INDUSTRIES INC | other | 2 Independence Way | N/A | Princeton | NJ | 08540-6620 | United States | 2026-09-25 | 2026-10-08 | 2026-10-14 | No data | Letter | US Nationwide. | Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Product of Canada, NDC 16714-249-02. | N/A | Failed Impurities/Degradation Specifications | Lot # AD96183, Exp Date: 12/31/2026. | No data | {"application_number": ["ANDA211644"], "brand_name": ["TRETINOIN"], "generic_name": ["TRETINOIN"], "manufacturer_name": ["NORTHSTAR RX LLC"], "product_ndc": ["16714-249"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["TOPICAL"], "substance_name": ["TRETINOIN"], "rxcui": ["106303"], "spl_id": ["39809045-c9fe-0fc5-e063-6394a90a60b0"], "spl_set_id": ["2e508351-eca3-427e-8d16-e840a84db0f5"], "package_ndc": ["16714-249-01", "16714-249-02"], "is_original_packager": [true], "nui": ["N0000175607", "M0018962"], "pharm_class_epc": ["Retinoid [EPC]"], "pharm_class_cs": ["Retinoids [CS]"], "unii": ["5688UTC01R"]} | 2026-10-27 |
| 23 | D-0032-2027 | drug | Drugs | 99867 | Ongoing | Class II | Voluntary: Firm initiated | Carolina Infusion, LLC | other | 95 Bees Creek Rd | N/A | Ridgeland | SC | 29936-7540 | United States | 2026-09-10 | 2026-10-08 | 2026-10-14 | No data | Nationwide within the U.S | Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 | 20 mLs - in patient specific syringe dose | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. | Lot: 07282026@2, BUD: 9/11/2026; 08032026@11, BUD: 9/17/2026; 08042026@3, BUD: 9/18/2026. . | No data | {} | 2026-10-27 | |
| 24 | D-0009-2027 | drug | Drugs | 99880 | Ongoing | Class II | Voluntary: Firm initiated | K.C. Pharmaceuticals, Inc. | other | 3420 Pomona Blvd | N/A | Pomona | CA | 91768-3236 | United States | 2026-09-11 | 2026-10-05 | 2026-10-14 | No data | US Nationwide | Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry and Irritated Eyes) Product size: 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 1429905619 0; c) Good Sense, Distributed By: Perrigo Direct Inc., Peachtree City, GA 30269, NDC 50804-160-01; d) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 20167 2. | 163,008 cartons | Lack of Assurance of Sterility | Lot: a) SU25B01, Exp.: 02/28/2027; b) SU25N01, Exp.: 11/30/2027; c) SU25B01, Exp.: 02/28/2027; SU25N01, Exp.: 11/30/2027; SU25N02, Exp.: 11/30/2027; d) SU25B01, Exp.: 02/28/2027. | No data | {"application_number": ["M018"], "brand_name": ["LEADER ULTRA LUBRICATING EYE DROPS", "GOODSENSE ULTRA LUBRICANT EYE DROPS"], "generic_name": ["POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL"], "manufacturer_name": ["Cardinal Health", "Geiss, Destin & Dunn, Inc."], "product_ndc": ["70000-0457", "50804-160"], "product_type": ["HUMAN OTC DRUG"], "route": ["OPHTHALMIC"], "substance_name": ["POLYETHYLENE GLYCOL 400", "PROPYLENE GLYCOL"], "rxcui": ["477589"], "spl_id": ["4ccccdc5-a8f7-6d26-e063-6394a90a8795", "474511c4-1fbd-70b8-e063-6294a90af8e8"], "spl_set_id": ["d7f011a2-05ba-47c3-9519-d31602e105c7", "9b45ebb5-c43b-c9fb-e053-2a95a90a3411"], "package_ndc": ["70000-0457-1", "70000-0457-2", "50804-160-01", "1429905619"], "is_original_packager": [true], "upc": ["0096295137101", "0846036008210", "614299056190", "311917201672"], "unii": ["B697894SGQ", "6DC9Q167V3"]} | 2026-10-27 | |
| 25 | D-0029-2027 | drug | Drugs | 99867 | Ongoing | Class II | Voluntary: Firm initiated | Carolina Infusion, LLC | other | 95 Bees Creek Rd | N/A | Ridgeland | SC | 29936-7540 | United States | 2026-09-10 | 2026-10-08 | 2026-10-14 | No data | Nationwide within the U.S | TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 | 24.8 mLs -in patient specific syringe dose | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. | Lot:08032026@23, BUD: 9/17/2026; 08172026@19, BUD: 10/1/2026; 08262026@13, BUD: 10/10/2026. | No data | {} | 2026-10-27 |
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