Memantine Hydrochloride Capsules Recalled for Failed Dissolution Specifications

Key Takeaways

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for memantine hydrochloride extended-release capsules, 7 mg. The affected batch has been identified as Lot N02425 (expiration date May 31, 2027).
• The recall was initiated by The Harvard Drug Group LLC due to failed dissolution specifications, a quality issue that may cause temporary or medically reversible adverse health consequences.
• Memantine hydrochloride capsules are used to treat moderate to severe Alzheimer disease.

The FDA has issued a Class II recall for memantine hydrochloride extended-release capsules, 7 mg. This medication is manufactured and distributed nationwide by Major Pharmaceuticals in Indianapolis, Indiana and is being recalled by The Harvard Drug Group LLC in Dublin, Ohio. The recall was initiated on March 24, 2026, and received a Class II classification on April 17, 2026.

The recall was initiated due to the product’s failure to meet dissolution requirements, specifically for Lot N02425, which has an expiration date of May 31, 2027. A Class II classification means the use of this product may cause temporary or medically reversible adverse health consequences, and the probability of serious adverse health consequences is low. The Harvard Drug Group sent out a public notice via letter; no public press release has been issued for this recall.

Memantine hydrochloride capsules are a prescription medication used to treat moderate to severe Alzheimer disease. Pharmacists should identify and quarantine Lot N02425, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. April 22, 2026. Accessed April 23, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219407