Drug recalls
Drug recall enforcement reports: the product, the firm, the reason and the recall class. 18,110 records; openFDA updated it 2026-11-10. About this dataset
Newest records
- Class II14,632
- Class I1,753
- Class III1,723
- Not Yet Classified2
- 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…
K.C. Pharmaceuticals, Inc. · Lack of Assurance of Sterility
- Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by:…
Cipla USA, Inc. · Failed Impurities/Degradation Specifications
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient pres…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Ma…
J&J INNOVATIVE MEDICINE · Presence of particulate matter.
- Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz (15 mL); a) Best Ch…
K.C. Pharmaceuticals, Inc. · Lack of Assurance of Sterility
- Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-0…
Apothecary Pharma LLC · Lack of Assurance of Sterility
- Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A., Inc., Prod# (NDC): 6…
Preferred Pharmaceuticals, Inc. · Failed Content Uniformity Specifications
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., B…
SUN PHARMACEUTICAL INDUSTRIES INC · Failed Impurities/Degradation Specifications
- TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific p…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry and Irritated Eyes) Product size: 0.5 fl o…
K.C. Pharmaceuticals, Inc. · Lack of Assurance of Sterility
- TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific p…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuti…
SUN PHARMACEUTICAL INDUSTRIES INC · Failed Impurities/Degradation Specifications
- Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML); a) exchange select, Manufactured for your Military Exchange By: K.C Pharmac…
K.C. Pharmaceuticals, Inc. · Lack of Assurance of Sterility
- TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific p…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25
BioSpectra, Inc. · Failed stability specifications
- Tri-Immune Boost (Glutathione: 200 mg, Ascorbic Acid: 200 mg, Zinc: 2.5 mg), 30 mL vial, Rx only, Centric Compounding, 7447 Harwin Dr. Suit…
Centric Compounding LLC · Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
- TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescripti…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DI…
K.C. Pharmaceuticals, Inc. · Lack of Assurance of Sterility
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.