Fenofibrate Capsules recall
FDA recall D-0611-2026 · initiated May 28, 2026
Ajanta Pharma USA Inc recalled Fenofibrate Capsules in May 2026 — an FDA Class II recall (D-0611-2026) because CGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 3648 bottles
Details
- Product
- Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04.
- Recalling company
- Ajanta Pharma Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- May 28, 2026
- FDA report date
- Jul 1, 2026
Frequently asked
- Was Fenofibrate Capsules recalled?
- Ajanta Pharma USA Inc recalled Fenofibrate Capsules in May 2026 — an FDA Class II recall (D-0611-2026) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Fenofibrate Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0611-2026 was: CGMP Deviations
- Is a recalled Fenofibrate Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Fenofibrate Capsules are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot # PA02216; Exp. 12/2029. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0611-2026.