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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 B12/E2/E3/PROG/TEST 1/3.75/2.5/50/45 MG/ML OIL INJ SOLN, all presentations, F... 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 COPPER 0.4MG/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 KETOROLAC TROMETHAMINE 60 MG/ML INJECTABLE, all presentations, FOR INTRAVENO... 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 TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN and TRI-MIX 30 MCG/15 MG/2 MG/ML INJ SO... 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 FREAMINE III ALT. 8.5% 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 PROCAINE P/F 20 MG/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 BUPRENORPHINE 0.1/0.05 MG/ML CREAM, 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 ESTRADIOL VALERATE W/ LIDOCAINE 1% 40 MG/ML OIL INJ SOLN, all configurations,... 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 PHOSPHATIDYLCHOLINE 50 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 NALBUPHINE HCL 20 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 PROGESTERONE 50 MG/ML OIL 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 DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTABLE, 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 BI-TROPIN S-2 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 MULTITRACE-5 INJECTABLE, all presentations, 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 LIPO-PLEX INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STER... 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 PROG/TEST CYP 15/7.5 MG/ML OIL INJ SOLN, 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 LIDOCAINE MDV 1% INJECTABLE, LIDOCAINE MDV 20 MG/ML INJECTABLE and Lidocaine ... 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 CALCIUM EDTA 300 MG/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 DMPS 50mg/ml INJECTABLE, all presentations, 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 METHYLPREDNISOLONE ACETATE 40 MG/ML and 80 MG/ML INJECTABLE, all presentatio... 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-12/LIDOCAINE 25/10MG/ML, 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 CALCIUM CHLORIDE 100 MG/ML 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 QUAD AMINO BLEND 150/75/150/75 MG/ML INJECTABLE, all presentations, FOR INTRA... 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 GLYCYRRHIZIC ACID 8 MG/ML 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 CALCIUM EDTA 200 MG/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 MAGNESIUM CHLORIDE HEXAHYDRATE 20% INJECTABLE, all presentations, FOR INTRAVE... 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 Zinc Sulfate 1 mg/ml INJECTABLE, all configurations, 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 OXYTOCIN 10 UNITS/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STER... 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 TRIAMCINOLONE ACETONIDE 80 MG/ML INJ SUSP, all configurations, FOR INTRAVENO ... 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/LIDO 100MG/2%/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO... 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 200 MG/ML (PF) 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 ASCORBIC ACID ( non-CORN SOURCE) 500 MG/ML INJECTABLE, 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 PARABEN WATER FOR INJECTION, 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 HYDROXOCOBALAMIN (VITAMIN B12A) 1 MG/ML INJECTABLE, 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 ESTRADIOL CYP/PROG/TEST CYP 0.5/10/10 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 25, 2013 Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL... Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes lab... Class III Hi-Tech Pharmacal Co., Inc.
Jul 24, 2013 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextro... Defective Container: There is a potential for frangible components to be broken, resulting in a l... Class II Baxter Healthcare Corp.
Jul 23, 2013 Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactur... Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (H... Class II Teva Pharmaceuticals USA, Inc.
Jul 22, 2013 METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic ... Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid an... Class I Mira Health Products Ltd.
Jul 22, 2013 Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Pras... Defective Container; This action is being taken as a precautionary measure due to the product bei... Class II Torrent Pharma Inc
Jul 22, 2013 B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count ... Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine whic... Class I Mira Health Products Ltd.
Jul 22, 2013 Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle ... Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17... Class I Mira Health Products Ltd.
Jul 19, 2013 Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bo... Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmet... Class I Herbal Give Care Llc
Jul 19, 2013 Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio,30 capsule bottle,... Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmet... Class I Herbal Give Care Llc
Jul 19, 2013 Volcano Male Enhancement Liquid, 2 FL OZ (60 ml) bottle, www.volcanoenhanceme... Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed ... Class I Myson Corporation, Inc.
Jul 19, 2013 Esbelin Siloutte Te, Suplemento Alimenticio, herbal tea in a gold foil/plasti... Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmet... Class I Herbal Give Care Llc
Jul 19, 2013 Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (... Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibit... Class III Bracco Diagnostics Inc
Jul 19, 2013 Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 cap... Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmet... Class I Herbal Give Care Llc
Jul 19, 2013 Volcano Male Enhancement 1500mg, 1-count capsule packaged in a black round pl... Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed ... Class I Myson Corporation, Inc.
Jul 19, 2013 Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico... Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmet... Class I Herbal Give Care Llc

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.