Dr. Reddy's Imatinib Tablets 100mg: Failed Dissolution Risk
Dr. Reddy's recalls 100mg Imatinib Mesylate tablets with failed dissolution specs. These tablets may not dissolve properly, affecting drug effectiveness. Contact for return instructions.
Lower-risk recall
Failed Dissolution Specifications
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What happened, in plain English
Dr. Reddy's is recalling 100mg Imatinib Mesylate tablets that failed dissolution tests. This could mean the medication doesn't work as intended, risking treatment failure for cancer patients. Read more at govinfonow.com/recall/36509-dr-reddy-s-imatinib-tablets-100mg-failed-dissolution-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36509-dr-reddy-s-imatinib-tablets-100mg-failed-dissolution-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0287-2021
Cite this page
“Dr. Reddy's Imatinib Tablets 100mg: Failed Dissolution Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36509-dr-reddy-s-imatinib-tablets-100mg-failed-dissolution-risk. Based on FDA recall #D-0287-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0287-2021%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications, meaning they may not dissolve properly in the body. This could lead to the medication not working effectively, potentially causing treatment failure for cancer patients.
Who’s affected
Patients prescribed Imatinib Mesylate 100mg tablets by doctors. Those using the recalled batches (NDC 43598-344-90 or 43598-344-31) are most at risk.
How to tell if you have this one
Check for 90-count bottles (NDC 43598-344-90) or 30-count cartons (NDC 43598-344-31) with lot numbers H2000206 or H2000138. These are prescription-only items.
- Brand
Dr. Reddy's- Category
Drug
What to do — step by step
Check Product Details
Identify the product by checking the NDC codes and lot numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0287-2021 (February 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0287-2021 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.