AVKARE Inc. recalls Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE,
AVKARE recalls 120-tablet mesalamine delayed-release tablets (Rx only) due to failed dissolution specifications. This may affect tablets with NDC 42291-564-12 and specific expiration dates.
Lower-risk recall
Failed Dissolution Specifications
Contact the company & request your remedy
What happened, in plain English
AVKARE is recalling mesalamine delayed-release tablets that may not dissolve properly as intended. This could lead to ineffective treatment for conditions like ulcerative colitis. Patients should contact their doctor for alternative options. Read more at govinfonow.com/recall/36693-avkare-mesalamine-tablets-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/36693-avkare-mesalamine-tablets-recall-failed-dissolution-specifications · Updated October 4, 2026 · FDA enforcement record: FDA #D-0070-2021
Cite this page
“AVKARE Mesalamine Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36693-avkare-mesalamine-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-0070-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0070-2021%22&limit=1).
Why it’s dangerous
The tablets may not dissolve correctly in the stomach, leading to ineffective treatment for ulcerative colitis. This could cause symptoms to persist or worsen without proper medication delivery.
Who’s affected
Patients prescribed mesalamine for ulcerative colitis who have the recalled tablets. Those with the specific NDC number and expiration dates listed are most at risk.
How to tell if you have this one
Check for the NDC number 42291-564-12 on the bottle. The recalled tablets have specific expiration dates: July 2021, January 2022, April 2022, and June 2022.
- Brand
AVKARE- Category
Drug
What to do — step by step
Contact Your Doctor
Talk to your healthcare provider about alternative treatment options for ulcerative colitis.
Questions people ask
Are these tablets safe to use?
The recall indicates the tablets may not dissolve properly, so they should not be used without consulting a doctor.
What is the NDC number for these tablets?
The NDC number is 42291-564-12.
Which expiration dates are affected?
The recalled tablets expire on July 2021, January 2022, April 2022, and June 2022.
Contact AVKARE
We’ve drafted a message you can send AVKARE to request your refund or repair — edit it as you like.
Subject: Recall D-0070-2021 — AVKARE AVKARE Hello, I own a AVKARE that is covered by recall D-0070-2021 from AVKARE. 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-0070-2021 (October 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0070-2021 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.