Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Famotidine Tablets Recalled by Glenmark Therapeutics, Inc. Due to Labeling: Label Error on Declared Strength: some cartons...

Date: May 1, 2023
Company: Glenmark Therapeutics, Inc.
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 Glenmark Therapeutics, Inc. directly.

Affected Products

Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.

Quantity: 19,968 bottles

Why Was This Recalled?

Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Glenmark Therapeutics, Inc.

Glenmark Therapeutics, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

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