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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
Mar 7, 2025 Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister c... Defective Container: blister packs not properly sealed resulting in tablets being loose in the ca... Class II ASEGUA THERAPEUTICS LLC
Sep 19, 2024 Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, M... Presence of Particulate Matter: Presence of glass particle. Class I Gilead Sciences, Inc.
Dec 3, 2021 Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, M... Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of... Class I Gilead Sciences, Inc.
Oct 1, 2014 Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Man... Defective Container; leaking around the cap Class II Gilead Sciences, Inc.
Sep 30, 2014 Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) table... Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates. Class III Gilead Sciences, Inc.
Feb 19, 2014 Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarat... Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug. Class III Gilead Sciences, Inc.
Jun 20, 2013 AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infu... Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bact... Class II Gilead Sciences, Inc.
Jan 31, 2013 Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx on... Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir ... Class I Gilead Sciences, 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.