Ajanta Pharma Fenofibrate Capsules Recall: CGMP Deviations Risk
Ajanta Pharma USA recalls 200mg Fenofibrate capsules due to CGMP deviations. Consumers should check NDC 27241-120-04 and lot # PA02216 for affected units.
Recall notice
CGMP Deviations
Contact the company
What happened, in plain English
Ajanta Pharma USA is recalling 200mg Fenof:ibrate capsules that were manufactured with CGMP deviations. This recall affects consumers who may have purchased these capsules from pharmacies or hospitals. Read more at govinfonow.com/recall/31264-ajanta-pharma-fenofibrate-capsules-recall-cgmp-deviations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31264-ajanta-pharma-fenofibrate-capsules-recall-cgmp-deviations-risk · Updated August 10, 2026 · FDA enforcement record: FDA #D-0611-2026
Cite this page
“Ajanta Pharma Fenofibrate Capsules Recall: CGMP Deviations Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31264-ajanta-pharma-fenofibrate-capsules-recall-cgmp-deviations-risk. Based on FDA recall #D-0611-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0611-2026%22&limit=1).
Why it’s dangerous
CGMP deviations refer to failures in the manufacturing process that could affect product quality and safety. These deviations might lead to inconsistent drug strength or impurities that could cause health risks.
Who’s affected
People who have purchased the 200mg Fenofibrate capsules with NDC 27241-120-04 and lot # PA02216 are affected. Prescriptions for this medication are typically for specific medical conditions.
How to tell if you have this one
Check for the NDC code 27241-120-04 and lot number PA02216 on the product packaging. The capsules are labeled as 200mg, prescription-only, and manufactured by Ajanta Pharma Limited in India.
- Brand
Ajanta Pharma- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 27241-120-04 and lot number PA02216 on the capsule packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 34 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-0611-2026 (May 28, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0611-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.