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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
May 17, 2024 Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, ... Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*,... Class III GlaxoSmithKline LLC
Dec 12, 2023 ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg.... Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification Class III GlaxoSmithKline LLC
May 13, 2022 Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured ... Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was print... Class III GlaxoSmithKline LLC
Sep 6, 2019 Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For... Temperature Abuse; Product stored and shipped outside of labeled storage requirements. Class II Cardinal Health dba Specialty Pharmaceutical Se...

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.