Browse Drug Recalls

6,306 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,306 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 6,306 FDA drug recalls.

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DateProductReasonClassFirm
Aug 23, 2013 L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... Class II Medaus, Inc.
Aug 23, 2013 NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS... Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind... Class II Wellness Pharmacy, Inc.
Aug 23, 2013 NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... Class II Medaus, Inc.
Aug 23, 2013 Lipo-Injection w/ Lidocaine (PF), Ascorbic Acid 50 mg; B1-50 mg; B2-5-PO4-5 m... Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... Class II Medaus, Inc.
Aug 23, 2013 Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solu... Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... Class II JCB Labs LLC
Aug 23, 2013 Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-80... Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... Class II Medaus, Inc.
Aug 23, 2013 NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... Class II Medaus, Inc.
Aug 16, 2013 Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic,... Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at ... Class II Hospira Inc.
Aug 13, 2013 CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medic... Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual... Class II Teva Pharmaceuticals USA, Inc.
Aug 12, 2013 Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Fo... Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials. Class II Hospira, Inc.
Aug 9, 2013 CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% ... Non Sterility: Microbial contamination Class I Specialty Compounding, LLC
Aug 9, 2013 All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd... Lack of Assurance of Sterility Class II Specialty Compounding, LLC
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.
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 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.

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.