Medications & Supplements/Prescription Drugs

Mycophenolic Acid Tablets Recalled for Failed Dissolution

Agency Publication Date: September 24, 2024

Summary

Approximately 117,493 bottles of Mycophenolic Acid Delayed-Release Tablets (360 mg) have been recalled because they failed dissolution testing. This medication is used to prevent organ rejection in transplant patients. "Failed dissolution" means the tablets may not dissolve at the correct rate, which could prevent the body from absorbing the medication properly and potentially reduce its effectiveness.

Risk

If the tablets do not dissolve correctly, patients may not receive the intended dose, which can increase the risk of organ rejection. There have been no reports of injuries or illnesses related to this recall at this time.

What You Should Do

This recall affects 360 mg Mycophenolic Acid Delayed-Release Tablets USP sold in 120-count bottles with NDC 67877-427-12.
Check the bottle label for NDC 67877-427-12 and the lot number printed on the container. See the Affected Products section below for the full list of affected codes.
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 Ascend Laboratories, LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 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: Mycophenolic Acid Delayed-Release Tablets USP, 360 mg (120 Tablets per bottle)

Variants: 360 mg, Delayed-Release Tablets

Lot Numbers:

22123437 (Exp Date 9/30/24)

22123438 (Exp Date 9/30/24)

22123535 (Exp Date 9/30/24)

22123536 (Exp Date 10/31/24)

22123537 (Exp Date 10/31/24)

22123538 (Exp Date 10/31/24)

22123646 (Exp Date 10/31/24)

22123647 (Exp Date 10/31/24)

23120529 (Exp Date 1/31/25)

23120530 (Exp Date 1/31/25)

23120703 (Exp Date 2/28/25)

23120705 (Exp Date 2/28/25)

23121429 (Exp Date 4/30/25)

23121726 (Exp Date 4/30/25)

23122049 (Exp Date 4/30/25)

23122097 (Exp Date 4/30/25)

23121984 (Exp Date 5/31/25)

23121985 (Exp Date 5/31/25)

23121986 (Exp Date 5/31/25)

23122325 (Exp Date 6/30/26)

23122329 (Exp Date 6/30/26)

23122330 (Exp Date 6/30/26)

23122331 (Exp Date 6/30/26)

23122776 (Exp Date 8/31/26)

23122852 (Exp Date 8/31/26)

23122853 (Exp Date 8/31/26)

23123154 (Exp Date 8/31/26)

23123155 (Exp Date 8/31/26)

23123458 (Exp Date 9/30/26)

NDC:

67877-427-12

Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95275

Status: Active

Manufacturer: Ascend Laboratories, LLC

Manufactured In: India

Units Affected: 117,493 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 360 mg Mycophenolic Acid Delayed-Release Tablets USP sold in 120-count bottles with NDC 67877-427-12.

Check the bottle label for NDC 67877-427-12 and the lot number printed on the container. See the Affected Products section below for the full list of affected codes.

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 Ascend Laboratories, LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 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: Mycophenolic Acid Delayed-Release Tablets USP, 360 mg (120 Tablets per bottle)

Variants: 360 mg, Delayed-Release Tablets

Lot Numbers:

22123437 (Exp Date 9/30/24)

22123438 (Exp Date 9/30/24)

22123535 (Exp Date 9/30/24)

22123536 (Exp Date 10/31/24)

22123537 (Exp Date 10/31/24)

22123538 (Exp Date 10/31/24)

22123646 (Exp Date 10/31/24)

22123647 (Exp Date 10/31/24)

23120529 (Exp Date 1/31/25)

23120530 (Exp Date 1/31/25)

23120703 (Exp Date 2/28/25)

23120705 (Exp Date 2/28/25)

23121429 (Exp Date 4/30/25)

23121726 (Exp Date 4/30/25)

23122049 (Exp Date 4/30/25)

23122097 (Exp Date 4/30/25)

23121984 (Exp Date 5/31/25)

23121985 (Exp Date 5/31/25)

23121986 (Exp Date 5/31/25)

23122325 (Exp Date 6/30/26)

23122329 (Exp Date 6/30/26)

23122330 (Exp Date 6/30/26)

23122331 (Exp Date 6/30/26)

23122776 (Exp Date 8/31/26)

23122852 (Exp Date 8/31/26)

23122853 (Exp Date 8/31/26)

23123154 (Exp Date 8/31/26)

23123155 (Exp Date 8/31/26)

23123458 (Exp Date 9/30/26)

NDC:

67877-427-12

Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC