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Browse Drug Recalls

9 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 9 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 9 FDA drug recalls.

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DateProductReasonClassFirm
Feb 4, 2026 Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x... Failed Impurities/Degradation Specifications - OOS impurities result observed during long term st... Class II SOMERSET THERAPEUTICS LLC
Nov 26, 2025 Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-... Subpotent product:out of specification assay results observed during long term stability testing. Class III SOMERSET THERAPEUTICS LLC
Nov 26, 2025 Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single... Subpotent product:out of specification assay results observed during long term stability testing. Class III SOMERSET THERAPEUTICS LLC
Nov 26, 2025 Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Mult... Subpotent product:out of specification assay results observed during long term stability testing. Class III SOMERSET THERAPEUTICS LLC
Dec 16, 2024 Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufact... Failed Impurities/Degradation Specifications Class III SOMERSET THERAPEUTICS LLC
Apr 24, 2024 Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vial... Presence of Foreign Substance: This oil based product may contain trace amounts of water for inje... Class II SOMERSET THERAPEUTICS LLC
Jun 4, 2020 Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactu... Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... Class III SOMERSET THERAPEUTICS LLC
Jun 4, 2020 Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufact... Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... Class III SOMERSET THERAPEUTICS LLC
Jun 4, 2020 Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufact... Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... Class III SOMERSET THERAPEUTICS 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.