Medications & Supplements/Over-the-Counter

Glenmark Famotidine 20mg Tablets Recalled for Labeling Error

Agency Publication Date: July 18, 2023

Summary

Glenmark Therapeutics, Inc. has recalled 19,968 bottles of Famotidine (20mg) tablets because of a labeling error regarding the drug's strength. While the bottles inside the cartons correctly contain 20mg tablets, an external label on the side of the carton may incorrectly state the strength as 10mg. No injuries or incidents have been reported in connection with this labeling error.

Risk

A consumer might take an incorrect dose of medication by relying on the 10mg strength label on the side of the carton when the product actually contains 20mg tablets. This could lead to a patient receiving double their intended dose, which may cause adverse health effects.

What You Should Do

This recall affects 200-count bottles of Famotidine Tablets, USP, 20mg, sold in cartons labeled with NDC 72657-113-20 and lot number FA2022001B with an expiration date of March 2025.
Check the external side label of the carton to see if it incorrectly lists the strength as 10mg while the rest of the packaging lists 20mg.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Glenmark Therapeutics, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Famotidine Tablets, USP (200-count bottle)

Variants: 20mg, Tablet

Lot Numbers:

FA2022001B (Exp 03/2025)

NDC:

72657-113-20

External label on side of carton may incorrectly indicate 10 mg strength; bottle inside is 20 mg.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92565

Status: Resolved

Manufacturer: Glenmark Therapeutics, Inc.

Sold By: pharmacies; drug distributors

Manufactured In: India, United States

Units Affected: 19,968 bottles

Distributed To: Nationwide

Agency Last Updated: July 21, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects 200-count bottles of Famotidine Tablets, USP, 20mg, sold in cartons labeled with NDC 72657-113-20 and lot number FA2022001B with an expiration date of March 2025.

Check the external side label of the carton to see if it incorrectly lists the strength as 10mg while the rest of the packaging lists 20mg.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Glenmark Therapeutics, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.