FDA recalls Carbamazepine Extended-Release Tablets, 400 mg, distributed nationwide by American Health Packaging. The recall cites failed dissolution specifications and class II classification. Consumers should stop using and contact healthcare providers for guidance.
Failed Dissolution Specifications.
Consumers and healthcare providers should stop using this product immediately. Contact Amerisource Health Services LLC or your healthcare provider for guidance. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Carbamazepine extended-release tablets are used to treat seizures and nerve pain. This recall involves 360 cartons distributed nationwide.
Failure to dissolve as specified can alter drug release and absorption, potentially impacting effectiveness and safety.
This recall is not part of a broader industry pattern.
The recall may affect adherence to prescribed therapy and require medical guidance for safe continuation.
On the carton and patient information leaflets; FDA enforcement page for D-0675-2025
Refund or replacement timelines will be provided in recall communications by Amerisource Health Services LLC and pharmacies
Keep the recall notice, receipts, and any correspondence with healthcare providers or pharmacies
Carbamazepine Extended-Release Tablets, USP 400 mg. 30 tablets per carton (3x10 unit dose cards). Rx Only. Distributor: American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; Individual Dose NDC 60687-594-11. Quantity: 360 cartons. Lot #: 1024078. Exp. Date: 08/31/2026. Sold nationwide in the USA. Generic name CARBAMAZEPINE; Brand CARBAMAZEPINE.
No injuries or incidents have been reported in the provided data.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Meclizine Hydrochloride Tablets distributed nationwide by Amerisource Health Services LLC are being recalled. The two affected NDCs are 60687-775-65 and 60687-775-11. The recall is due to failed tablet specifications. Stop using the product and contact a healthcare provider for guidance immediately.
KVK-Tech Inc. recalled 31,676 packages of Oxycodone Hydrochloride Tablets on January 14, 2026. Defective seals may cause tablets to fall out, posing a health risk. Customers should stop using the product immediately and seek guidance from healthcare providers.
27,868 blister packs of Sucralfate Tablets, 1 g, distributed nationwide by American Health Packaging are recalled. The recall stems from CGMP deviations that prevent the firm from assuring product identity, strength, quality and purity. Health providers and consumers should stop using the product immediately and await guidance.
A recall of chlorpromazine hydrochloride tablets is active nationwide in the United States. A specific lot of packaging material to coils used in manufacturing contained a foreign substance with a microorganism detected. Tablets themselves tested negative for microorganisms. Consumers and healthcare providers should stop using the product immediately and contact Amerisource Health Services LLC or
Chlorpromazine Hydrochloride tablets distributed nationwide by American Health Packaging are recalled after a polyester coil used in packaging showed presence of a micro-organism in a specific lot. No tablets were contaminated. Consumers and healthcare providers should stop using this product immediately and contact Amerisource Health Services LLC for guidance.
American Health Packaging recalled 873 cartons of Chlorpromazine Hydrochloride Tablets, USP, 200 mg, after foreign substances were detected in product packaging. A specific lot of auxiliary polyester coil contained a micro-organism, posing a high health risk. Consumers should stop using the product immediately and contact their healthcare provider for guidance.
A high-severity recall covers chlorpromazine hydrochloride tablets distributed nationwide by American Health Packaging. A foreign substance linked to a polyester coil packaging component was detected at the manufacturing site. No tablets were contaminated. Stop using the product and contact the distributor for guidance.
A recall is active for Sucralfate Tablets, USP 1 gram distributed by American Health Packaging. The firm filed for Chapter 11 in September 2024, triggering CGMP deviations and questions about product identity, strength, quality and purity. The recall affects 26,992 blister packs distributed nationwide. Stop using the product and contact Amerisource Health Services or your clinician for guidance.