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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Mercaptopurine Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: March 6, 2024
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Summary

Stason Pharmaceuticals, Inc. has recalled 54, 131 bottles of Mercaptopurine Tablets, USP 50 mg, which are distributed under the Quinn Pharmaceuticals brand. The recall was issued because the medication failed dissolution testing at the nine-month mark, meaning the tablets were not dissolving as quickly as required by quality standards. This recall affects both 25-count and 250-count bottles from specific production lots with expiration dates in 2024. If you are taking this medication, you should consult with your healthcare provider or pharmacist regarding your treatment.

Risk

If the tablets do not dissolve properly, the body may not absorb the intended amount of the medication, which could potentially reduce the effectiveness of the treatment for the patient's condition.

What You Should Do

  1. This recall affects Mercaptopurine Tablets, USP 50 mg, sold in 25-count bottles (NDC 69076-913-02) and 250-count bottles (NDC 69076-913-25) manufactured for Quinn Pharmaceuticals.
  2. Identify if your medication is affected by checking for lot numbers such as 22K012, 22K013A, 23A001, 23A002A, 23D006, 23D007A, 23D007C, 22K013B, 23A002B, or 23D007B with expiration dates between April and October 2024. See the Affected Products section below for the full list of affected codes.
  3. 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 Quinn Pharmaceuticals at www.quinnrx.com for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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: Mercaptopurine Tablets, USP 50 mgby Quinn Pharmaceuticals
Variants: 50 mg, Tablet, 25-count bottle, 250-count bottle
Lot Numbers:
22K012 (Exp: 04/30/2024)
22K013A (Exp: 04/30/2024)
23A001 (Exp: 07/31/2024)
23A002A (Exp: 07/31/2024)
23D006 (Exp: 10/31/2024)
23D007A (Exp: 10/31/2024)
23D007C (Exp: 10/31/2024)
22K013B (Exp: 04/30/2024)
23A002B (Exp: 07/31/2024)
23D007B (Exp: 10/31/2024)
NDC:
69076-913-02
69076-913-25

Manufactured for Quinn Pharmaceuticals, Boca Raton, FL.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93960
Status: Resolved
Manufacturer: Stason Pharmaceuticals, Inc.
Sold By: Quinn Pharmaceuticals
Manufactured In: United States
Units Affected: 54, 131 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 ยท 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.