Teva Pharmaceuticals USA recalls Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL,
Teva Pharmaceuticals USA recalls 1.2g Mesalamine Delayed-Release Tablets due to failed dissolution testing. This may affect medication effectiveness. Check NDC 0591-2245-2: 120-count bottle, Rx only, manufactured by Actavis Laboratories.
Lower-risk recall
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Contact the company & request your remedy
What happened, in plain English
Teva Pharmaceuticals USA is recalling 1.2 gram Mesalamine Delayed-Release Tablets (120-count bottles) because they failed dissolution testing. This could mean the medication doesn't work properly as intended. Read more at govinfonow.com/recall/37370-teva-mesalamine-tablets-recall-failed-dissolution-testing-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37370-teva-mesalamine-tablets-recall-failed-dissolution-testing-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0862-2020
Cite this page
“Teva Mesalamine Tablets Recall: Failed Dissolution Testing Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37370-teva-mesalamine-tablets-recall-failed-dissolution-testing-risk. Based on FDA recall #D-0862-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0862-2020%22&limit=1).
Why it’s dangerous
The tablets failed dissolution testing during stability checks, meaning they might not release the medication properly in the body. This could affect how well the medication works for treating ulcerative colitis.
Who’s affected
People with ulcerative colitis who need this medication. Those who have the specific bottle with NDC 0591-2245-22 are most at risk.
How to tell if you have this one
Check for the 120-count bottle labeled 'Mesalamine Delayed-Release Tablets, USP, 1.2 gram'. The NDC code is 0591-2245-22. The lot number is 1342500A, expiring 10/2020.
- Brand
Teva Pharmaceuticals USA- Category
Drug
What to do — step by step
Check Medication Details
Look for the NDC code 0591-2245-22 on the bottle label to confirm it's the recalled product.
Questions people ask
Is this medication dangerous?
The recall is due to failed dissolution testing, which may affect medication effectiveness, but it does not pose a safety risk like injury or death.
How do I know if I have the recalled product?
Check for the NDC code 059:1-2245-22 on the bottle label. The product is a 120-count bottle of Mesalamine Delayed-Release Tablets, USP, 1.2 gram, manufactured by Actavis Laboratories.
What should I do if I have this product?
The recall record does not specify a remedy, so contact your doctor or pharmacist for guidance.
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-0862-2020 — Teva Pharmaceuticals USA Teva Pharmaceuticals USA Hello, I own a Teva Pharmaceuticals USA that is covered by recall D-0862-2020 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-0862-2020 (February 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0862-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.