Medications & Supplements/Prescription Drugs

Carbamazepine Extended-Release Tablets Recalled for Failed Dissolution

Agency Publication Date: September 29, 2025

Summary

Amerisource Health Services LLC is recalling 360 cartons of American Health Packaging Carbamazepine Extended-Release Tablets (400 mg). This medication, used to treat seizures and nerve pain, is being recalled because it failed dissolution specifications during testing. This means the tablets may not release the medication properly in the body, potentially leading to lower-than-intended blood levels of the drug.

Risk

If the extended-release mechanism fails, the medication may release too slowly or incompletely, which could lead to a loss of seizure control or a return of neuropathic pain for the patient.

What You Should Do

Check your medication carton and individual dose cards for Carbamazepine Extended-Release Tablets, USP 400 mg, manufactured by American Health Packaging.
Identify if your product is affected by looking for Lot # 1024078 with an Expiration Date of 08/31/2026. The carton is labeled with NDC 60687-594-21 and individual dose cards are labeled with NDC 60687-594-11.
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 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 Extended-Release Tablets, USP 400 mg (30 Tablets per carton)by American Health Packaging

Variants: 400 mg, Extended-Release Tablet, Rx Only

Lot Numbers:

1024078 (Exp. 08/31/2026)

NDC:

60687-594-21

60687-594-11

Distributed in 3x10 unit dose cards.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97634

Status: Active

Manufacturer: Amerisource Health Services LLC

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 360 cartons

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

Check your medication carton and individual dose cards for Carbamazepine Extended-Release Tablets, USP 400 mg, manufactured by American Health Packaging.

Identify if your product is affected by looking for Lot # 1024078 with an Expiration Date of 08/31/2026. The carton is labeled with NDC 60687-594-21 and individual dose cards are labeled with NDC 60687-594-11.

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 questions.