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
Jan 4, 2024 Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle,... Labeling: Label Mix-up Class I Azurity Pharmaceuticals, Inc.
Dec 8, 2023 Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufa... Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylid... Class III Azurity Pharmaceuticals, Inc.
Feb 15, 2023 Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL... cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. Class II Azurity Pharmaceuticals, Inc.
Aug 24, 2021 Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit... Product Mix-up: Incorrect diluent component included in the kit. Class I Azurity Pharmaceuticals, 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.