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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
Mar 14, 2016 Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL... Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the... Class II Meditech Laboratories, Inc
Mar 14, 2016 Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL... Superpotent Drug: one ingredient was found to be above assay specification. Class II Meditech Laboratories, Inc
Mar 14, 2016 Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 m... Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the... Class II Meditech Laboratories, Inc
Mar 14, 2016 Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/m... Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the... Class II Meditech Laboratories, Inc
Mar 14, 2016 Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 m... Lack of Assurance of Sterility: incomplete or missing data regarding production. Class II Meditech Laboratories, Inc
Mar 14, 2016 Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection... Lack of Assurance of Sterility: incomplete or missing data regarding production. Class II Meditech Laboratories, Inc
Mar 14, 2016 Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratori... Lack of Assurance of Sterility: incomplete or missing data regarding production. Class II Meditech Laboratories, Inc

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.