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Browse Drug Recalls

7 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 7 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 7 FDA drug recalls.

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DateProductReasonClassFirm
Jul 6, 2017 Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Onl... Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-re... Class III Hospira Inc., A Pfizer Company
May 18, 2017 Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx o... GMP Deviation; A foreign stopper was observed during packaging of a lot of product. Class II Hospira Inc., A Pfizer Company
Feb 10, 2017 METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible ... Lack of Sterility Assurance: customer report of leaking bag Class II Hospira Inc., A Pfizer Company
Jan 24, 2017 Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package ... Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. Th... Class I Hospira Inc., A Pfizer Company
Sep 16, 2016 Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL... Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from fo... Class II Hospira Inc., A Pfizer Company
Sep 16, 2016 Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50... Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from fo... Class II Hospira Inc., A Pfizer Company
Aug 4, 2016 Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Sing... Presence of particulate matter: Confirmed customer report for the presence of particulate matter ... Class I Hospira Inc., A Pfizer Company

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.