Medications & Supplements/Prescription Drugs

Topiramate 50 mg Tablets Recalled Due to Discoloration

Agency Publication Date: November 19, 2021

Summary

Unichem Pharmaceuticals USA Inc has recalled 1,284 bottles of Topiramate (50 mg), a prescription medication used to treat seizures and prevent migraines. The recall was initiated because the tablets were found to be discolored. If you are taking this medication, you should consult your healthcare provider or pharmacist regarding the discoloration and the safety of your supply.

Risk

The tablets have exhibited discoloration, which is a physical defect that deviates from the product's quality standards. While no injuries have been reported, discolored medication may indicate degradation or compromised integrity.

What You Should Do

This recall involves Topiramate Tablets, USP (50 mg) packaged in 500-count bottles with NDC 29300-116-05, manufactured for Unichem Pharmaceuticals (USA), Inc.
Identify if your medication is affected by checking the label for lot number ZTPM20044 with an expiration date of 09/30/2022.
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 the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

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: Topiramate Tablets, USP 50 mg (500-count bottle)

Variants: 50 mg, Tablet

Lot Numbers:

ZTPM20044 (Exp. Date 09/30/2022)

NDC:

29300-116-05

Manufactured by: Unichem Laboratories LTD, Ghaziabad, India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88891

Status: Resolved

Manufacturer: UNICHEM PHARMACEUTICALS USA INC

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 1284 bottles

Distributed To: Nationwide

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 involves Topiramate Tablets, USP (50 mg) packaged in 500-count bottles with NDC 29300-116-05, manufactured for Unichem Pharmaceuticals (USA), Inc.

Identify if your medication is affected by checking the label for lot number ZTPM20044 with an expiration date of 09/30/2022.

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 the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.