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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Mesalamine Delayed-Release Tablets Recalled for Failed Dissolution

Agency Publication Date: November 6, 2020
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Summary

Teva Pharmaceuticals USA is recalling 133,829 bottles of Mesalamine Delayed-Release Tablets (1.2 gram, 120-count bottles) because the medication failed stability testing. Testing showed the tablets were not dissolving at the required rate, which is critical for how the medication is absorbed by the body. This prescription drug, used to treat certain bowel conditions, was manufactured by Actavis Laboratories and distributed nationwide across the United States and Puerto Rico.

Risk

If the tablets do not dissolve as intended, the medication may not be released correctly in the gastrointestinal tract, potentially leading to a lack of efficacy or a reduction in the treatment's intended benefits.

What You Should Do

  1. Check your Mesalamine Delayed-Release Tablet bottle for NDC 0591-2245-22 and a bottle size of 120 tablets.
  2. Locate the lot number on the side of the bottle. Affected lots include: 1342498A (Exp. 12/2020), 1342499A (Exp. 01/2021), 1354638A (Exp. 03/2021), 1354639A, 1358274A, 1358448A, 1364618A, 1369884A (Exp. 05/2021), 1366195A, 1369885A, 1373570A (Exp. 06/2021), 1373571A (Exp. 07/2021), 1388571A (Exp. 01/2022), 1395725A, 1396585A, 1397550A, 1399389A (Exp. 04/2022), 1403885A, and 1403886A (Exp. 06/2022).
  3. Contact your healthcare provider or pharmacist immediately to discuss whether your treatment is affected and to obtain a replacement prescription if necessary.
  4. Return any unused tablets from the affected lots to your pharmacy for a refund and contact Teva Pharmaceuticals USA or Actavis Pharma Inc. for further instructions.
  5. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Mesalamine Delayed-Release Tablets, USP (1.2 gram, 120 tablets per bottle)
Model:
NDC 0591-2245-22
Lot Numbers:
1342498A (Exp. 12/2020)
1342499A (Exp. 01/2021)
1354638A (Exp. 03/2021)
1354639A (Exp. 05/2021)
1358274A (Exp. 05/2021)
1358448A (Exp. 05/2021)
1364618A (Exp. 05/2021)
1369884A (Exp. 05/2021)
1366195A (Exp. 06/2021)
1369885A (Exp. 06/2021)
1373570A (Exp. 06/2021)
1373571A (Exp. 07/2021)
1388571A (Exp. 01/2022)
1395725A (Exp. 04/2022)
1396585A (Exp. 04/2022)
1397550A (Exp. 04/2022)
1399389A (Exp. 04/2022)
1403885A (Exp. 06/2022)
1403886A (Exp. 06/2022)
Date Ranges: December 2020, January 2021, March 2021, May 2021, June 2021, July 2021, January 2022, April 2022, June 2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86667
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 133,829 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.