Browse Drug Recalls

4 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 4 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 4 FDA drug recalls.

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DateProductReasonClassFirm
Feb 20, 2024 Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured fo... Defective Container: Out of specification for weight due to a slow leakage at the 12-month stabil... Class III Contract Pharmaceuticals Limited Canada
Feb 20, 2024 Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured... Defective Container: Out of specification for weight due to a slow leakage at the 12-month stabil... Class III Contract Pharmaceuticals Limited Canada
Aug 23, 2023 Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufa... Defective Container: slow leakage under the cap Class III Contract Pharmaceuticals Limited Canada
Mar 28, 2017 PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL b... Failed Stability Specifications Class III Teva Pharmaceuticals USA

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.