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Browse Drug Recalls

2,085 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,085 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 2,085 FDA drug recalls in 2013.

Clear
DateProductReasonClassFirm
Jul 26, 2013 SODIUM BICARBONATE PF 8.4% INJECTABLE, all presentations, FOR INTRAVENO AND S... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 SODIUM PHOSPHATE MONOBASIC/WATER FOR INJECTION 10%, all presentations, FOR IN... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 EDETATE DISODIUM 150 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND ... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 ESTRADIOL CYPIONATE 5, 10, 40 MG/ML OIL INJ SOLN, all configuration, FOR INTR... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 MIC-CARN MAX 15/100/50/1 MG/ML INJECTABLE, all presentations, FOR INTRAVENO a... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 DEXPANTHENOL 250 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ U... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 HYALURONIDASE 150 U/ML and 200 U/ML INJECTABLE, all presentations, FOR INTR... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 DUAL-TESTOSTERONE 20, 50, 100, 150, 200 MG/ML OIL INJ SOLN, all presentations... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 SERMORELIN ACETATE 10 MG INJECTABLE, all presentations, FOR INTRAVENO AND SQ ... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 PYRIDOXINE HCL P/F 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AN... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 VITAMIN B-COMPLEX INJECTABLE, VITAMIN B-COMPLEX SL SOLN and VITAMIN B-COMPLEX... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 ASCORBIC ACID (CORN SOURCE) 500 MG/ML INJECTABLE, all configurations, FOR INT... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 GLYCINE 50 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 NALTREXONE 1 MG/ML INJECTABLE and 200 MG/ML INJECTABLE, all presentations, FO... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 MAGNESIUM SULFATE 50% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTR... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 METHYLCOBALAMIN 1 mg/ml, 5 mg/ml, 10 mg/ml, 25 mg/ml and METHYLCOBALAMIN (PF... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 CHROMIUM 4 MCG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONL... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 GLUTATHIONE/METHYL/LIDO 100/25/20 MG/ML INJ SOLN and GLUTATHIONE/METHYL/LIDO... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 MANGANESE SULFATE 0.1 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AN... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 GLUTAMINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONL... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 NANDROLONE DECANOATE 100 MG/ML and 200 MG/ML OIL INJ SOLN, all presentations,... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 LIPOIC ACID 100 MG/ML and 200 MG/ML INJECTABLE, all presentations, FOR INTRAV... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 L-TRYPTOPHAN 300 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ US... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 ARGININE (R-GENE) 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND ... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 MIC-CARN + B6/B12/LIDOCAINE 25/50/50/175MCG/1/0.1MG/ML INJECTABLE, all presen... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 SELENIUM 400 MCG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 ESTRIOL 5 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONL... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 SODIUM HYDROXIDE 10% (W/V)/WATER FOR INJECTION, all presentations, FOR INTRAV... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 CYANOCOBALAMIN 1000 MCG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 B-COMPLEX/LIDO/B-12, 25MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL INJ SOLN, all presentations, FOR ... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 PUMICE/LIDOCAINE HCL 1.5%/1% INJ SUSP, all presentations, FOR INTRAVENO AND S... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 ALPROSTADIL 100 MCG/ML INJ SOLN, all sizes, FOR INTRAVENO AND SQ USE ONLY, ST... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 H.C.G. (COMPOUNDED), 5,000, 8, 000, 10,000, 11,000 and 12,000 UNIT VIALS INJE... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/ML, 20 MG/ML OIL INJ SOLN, all conf... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 POTASSIUM CHLORIDE 2 MEQ/ML INJECTABLE, all presentations, FOR INTRAVENO AND ... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 BI-MIX PHENTOLAMINE/PAPAVERINE 0.5 MG/30 MG/ML and BI-MIX PHENTOLAMINE/PAPAVE... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 TRIPLE-TESTOSTERONE 250 MG/ML OIL INJ SOLN and TRIPLE-TESTOSTERONE 200 MG/ML ... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 TESTOSTERONE PROPIONATE 100 MG/ML OIL INJ SOLN, all configuration, FOR INTRAV... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 VITAMIN D 50,000 I.U./ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 B-COMPLEX/LIDOCAINE 2% INJECTION, all presentations, FOR INTRAVENO AND SQ USE... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 DMSO 50% INJ 50 ML VIAL INJECTABLE, all presentations, FOR INTRAVENO AND SQ U... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 DEXTROSE PF 50% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 HYDROGEN PEROXIDE 3% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 ACETYLCYSTEINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ U... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 FUROSEMIDE 10 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE O... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 ALPROSTADIL, 50 MCG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.
Jul 26, 2013 TRIPTROPIN PLUS INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY... Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... Class II Beacon Hill Medical Pharmacy, P.C.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.