Medications & Supplements/Prescription Drugs

Carbamazepine Tablets Recalled for Failed Dissolution

Agency Publication Date: January 11, 2022

Summary

Torrent Pharma Inc. is recalling 15,336 Bottles of Carbamazepine Tablets, USP (200 mg). This prescription medication is being recalled because the tablets failed to meet dissolution specifications, which means the drug may not dissolve properly in the body to release the active ingredient. If you are taking this medication, you should contact your healthcare provider or pharmacist for guidance.

Risk

If the tablets do not dissolve correctly, the patient may not receive the intended dose of the medication. This could lead to a loss of seizure control or an increase in other symptoms the drug is prescribed to treat. No incidents or injuries have been reported to date.

What You Should Do

This recall affects 100-tablet bottles of Carbamazepine Tablets, USP 200 mg (NDC 13668-268-01) manufactured for Torrent Pharma Inc. with batch number 4J11G002 and an expiration date of 08/2024.
Identify if you have the affected product by checking the batch code 4J11G002 and expiration date 08/2024 printed on the bottle label.
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 Torrent Pharma 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: Carbamazepine Tablets, USP 200 mg (100 Tablets)

Variants: 200 mg, Tablet

Lot Numbers:

4J11G002 (Exp. 08/2024)

NDC:

13668-268-01

Quantity: 15,336 Bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89146

Status: Resolved

Manufacturer: Torrent Pharma Inc.

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 15,336 Bottles

Distributed To: Nationwide

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 100-tablet bottles of Carbamazepine Tablets, USP 200 mg (NDC 13668-268-01) manufactured for Torrent Pharma Inc. with batch number 4J11G002 and an expiration date of 08/2024.

Identify if you have the affected product by checking the batch code 4J11G002 and expiration date 08/2024 printed on the bottle label.

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 Torrent Pharma Inc. for further instructions.

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