Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Memantine Hydrochloride Extended-Release Capsules Recalled by The Harvard Drug Group Due to Failed dissolution specifications: Low stage 3 results obtained...

Date: April 24, 2020
Company: The Harvard Drug Group
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact The Harvard Drug Group directly.

Affected Products

Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61

Quantity: 678 cartons

Why Was This Recalled?

Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.

Where Was This Sold?

This product was distributed to 6 states: AL, FL, IA, NY, OH, TX

Affected (6 states)Not affected

About The Harvard Drug Group

The Harvard Drug Group has 45 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report