Teva Pharmaceuticals USA recalls Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis
Teva Pharmaceuticals USA recalls specific lots of Mesalamine Delayed-Release Tablets due to failed dissolution testing. Consumers should contact the company for details.
Lower-risk recall
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Contact the company & request your remedy
What happened, in plain English
Teva Pharmaceuticals USA is recalling certain lots of Mesalamine Delayed-Release Tablets because they failed dissolution testing. This could mean the medication doesn't work properly as intended. Read more at govinfonow.com/recall/36694-teva-mesalamine-tablets-recall-failed-dissolution-testing.
Source Summary by GovInfoNow · govinfonow.com/recall/36694-teva-mesalamine-tablets-recall-failed-dissolution-testing · Updated October 4, 2026 · FDA enforcement record: FDA #D-0069-2021
Cite this page
“Teva Mesalamine Tablets Recall: Failed Dissolution Testing.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36694-teva-mesalamine-tablets-recall-failed-dissolution-testing. Based on FDA recall #D-0069-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0069-2021%22&limit=1).
Why it’s dangerous
The tablets failed dissolution testing during stability checks, meaning they may not release the medication correctly in the body. This could affect how well the drug works for treating ulcerative colitis.
Who’s affected
People with prescription mesalamine for ulcerative colitis who own the recalled lots. Those with the specific lot numbers listed in the recall are most at risk.
How to tell if you have this one
Check the product label for the lot numbers listed: 1342498A through 1403886A. The tablets are prescription-only and come in 120-count bottles.
- Brand
Teva Pharmaceuticals USA- Category
Drug
What to do — step by step
Check Product Label
Look for the lot numbers listed in the recall: 1342498A through 1403886A.
Questions people ask
What is the hazard with these tablets?
The tablets failed dissolution testing during stability checks, meaning they may not release the medication correctly in the body.
How do I know if I have the recalled product?
Check the product label for lot numbers: 1342498A through 1403886A.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact Teva Pharmaceuticals USA for further instructions.
Contact Teva Pharmaceuticals USA
We’ve drafted a message you can send Teva Pharmaceuticals USA to request your refund or repair — edit it as you like.
Subject: Recall D-0069-2021 — Teva Pharmaceuticals USA Teva Pharmaceuticals USA Hello, I own a Teva Pharmaceuticals USA that is covered by recall D-0069-2021 from Teva Pharmaceuticals USA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0069-2021 (October 28, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0069-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.