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Browse Drug Recalls

8 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 8 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 8 FDA drug recalls.

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DateProductReasonClassFirm
Apr 2, 2024 Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent... Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect... Class III X-Gen Pharmaceuticals Inc.
Apr 2, 2024 Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, ... Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect... Class III X-Gen Pharmaceuticals Inc.
Mar 19, 2021 Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, M... Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological ... Class II X-Gen Pharmaceuticals Inc.
Oct 11, 2019 Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manuf... Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached. Class III X-Gen Pharmaceuticals Inc.
Mar 29, 2019 Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, ... Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration... Class III X-Gen Pharmaceuticals Inc.
May 17, 2017 Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle... Presence of Foreign Substance: potential presence of plastic particles. Class II X-Gen Pharmaceuticals Inc.
Feb 8, 2017 Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC... Presence of Particulate Matter Class I X-Gen Pharmaceuticals Inc.
Jul 17, 2014 Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, ... Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each m... Class III X-Gen 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.