514 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.
Looking for a specific drug? Use the search page to find recalls by medication name, manufacturer, or NDC number.
Great Lakes Wholesale International recalled select battery packs on November 13, 2025. The battery packs lack child-resistant packaging and pose a serious ingestion risk for children. Consumers should stop using the products immediately and seek refunds.
Lifepro Fitness recalled Bioremedy Infrared Sauna Blankets on October 23, 2025, due to burn hazards. The recall affects all models with a gray-faced control pad. Consumers should stop using the blankets immediately.
LEACHOI recalled its adult portable bed rails on October 23, 2025, due to serious entrapment and asphyxiation hazards. The recalled product violates mandatory safety standards for bed rails and poses a high risk of injury or death. Consumers should stop using the bed rails immediately and seek a full refund.
Bristol-Myers Squibb recalled 12,778 vials of Opdualag injection on October 21, 2025. The recall stems from a lack of assurance of sterility. The affected products were distributed nationwide in the United States.
Major Pharmaceuticals recalled Gabapentin Capsules, USP, 100 mg, on October 10, 2025, due to failed impurities specifications. The recall affects several lot numbers distributed nationwide. Consumers must stop using the affected capsules immediately.
Lannett Company, Inc. recalled 46,848 bottles of Niacin Extended-release Tablets on October 10, 2025. The recall follows reports of failed dissolution specifications, which could affect medication effectiveness. Consumers should stop using the product immediately and consult healthcare providers for guidance.
Major Pharmaceuticals recalled Gabapentin Capsules, USP, 100 mg on October 10, 2025, due to failed stability testing. The recall affects capsules packaged in blister packs and sold nationwide. Consumers must stop using the product immediately and seek guidance from healthcare providers.
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
USV Private recalled 8,952 bottles of Olopatadine Hydrochloride Ophthalmic Solution on October 9, 2025. The solution exceeded impurity specifications, posing a health risk. Consumers should stop using the product immediately and contact their healthcare provider.
Taoscare recalled 3 boxes of motion sickness patches on October 9, 2025. The product was marketed without an approved NDA/ANDA. Consumers should stop using the patches immediately and seek guidance.
Lack of Assurance of Sterility:
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Discoloration - Expansion of RES #97424
Almpal recalled dissolved oxygen test kits on October 2, 2025. The kits contain unchild-resistant sulfuric acid, posing a poisoning risk to children. Consumers should stop using these kits immediately and secure them out of reach of children.
ICU Medical recalled 23,203 IV administration sets on October 2, 2025. The sets lack an internal shutoff valve, risking fluid over-delivery and air infusion. This recall affects devices distributed worldwide, including the U.S., Canada, Australia, and New Zealand.
Abiomed issued a recall for 10,153 Automated Impella Controllers on October 1, 2025. The devices face potential cybersecurity vulnerabilities related to their operating system. Healthcare providers and patients should stop using these devices immediately.
Church & Dwight Co., Inc. recalled 21,912 bottles of ZICAM Medicated Fruit Drops on October 1, 2025. The recall stems from a labeling mix-up that failed to disclose elderberry as an ingredient. Consumers should stop using the product immediately.
Camber Pharmaceuticals, Inc. recalled Ketorolac Tromethamine Injection on October 1, 2025. The recall affects a specific lot due to the presence of glass particles. This recall pertains to the 60 mg/2 mL single-dose vials distributed nationwide.
B BRAUN MEDICAL recalled 1,298,454 hemodialysis bloodlines on September 30, 2025. The recall results from the risk of micro-air bubbles due to damaged connectors. Patients should stop using the product immediately and follow the manufacturer’s instructions.
Acuity Specialty Products recalled its Wyandotte Sanifect E3 hand sanitizer on September 29, 2025. The recall affects multiple package configurations due to potential methanol contamination. Consumers should stop using the product immediately and contact the company for guidance.
AFCO recalled hand sanitizer on September 29, 2025, due to a risk of methanol contamination. The company failed to conduct required testing on incoming alcohol components. Consumers should stop using the product immediately.
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