Acamprosate Calcium Tablets Recalled Due to Failed Dissolution Specifications

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for acamprosate calcium delayed-release tablets, 333 mg. The affected batch has been identified as Lot 3227809 (expires October 2026).
• The recall was initiated by Mylan Pharmaceuticals, Inc due to failed dissolution specifications, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Acamprosate is used to manage alcohol use disorder.

The FDA has issued a Class II recall for acamprosate calcium delayed-release tablets, 333 mg. This product is being recalled by Mylan Pharmaceuticals, Inc based in Morgantown, West Virgina. The recall was initiated on July 24, 2026, and received a Class II classification on August 19, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to the product’s failure to meet dissolution specifications. This deficiency affects Lot 3227809, which will expire in October 2026. Mylan Pharmaceuticals sent out a public notice via letter; no press release has been issued for this recall.

Acamprosate is a prescription medication used to help people with alcohol use disorder. It helps people abstain from drinking by preventing cravings. Pharmacists should identify and quarantine Lot 3227809, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. August 26, 2026. Accessed August 26, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221655