FDA recall, , Moderate risk
Ajanta Pharma Fenofibrate Capsules
Fenofibrate Capsules, USP 200 mg, have CGMP deviations.
Summary by Recall Canary from the FDA notice
What happened
Ajanta Pharma USA Inc. of Bridgewater, New Jersey, recalled Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, due to CGMP deviations. The product was manufactured by Ajanta Pharma Limited, India, and marketed by Ajanta Pharma USA Inc. The recall began on May 28, 2026, and was added to the FDA's Enforcement Report on June 22, 2026, with distribution nationwide in the U.S.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Fenofibrate Capsules, USP 200 mg
- NDC
- 27241-120-04
- Lot code
- PA02216
Recall details
- Company began the recall
- Sold in
U.S. Nationwide
- Company
- Ajanta Pharma USA IncBridgewater, New Jersey
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99130
- Recall number
- D-0611-2026
- Quantity recalled
- 3648 bottles
All recalls from Ajanta Pharma USA Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
