CLASS II ONGOING Drug recall · Reported 1 Jul 2026 · FDA Enforcement Report
Fenofibrate Capsules, USP 200 mg recalled by Ajanta Pharma USA
Ajanta Pharma USA is recalling Fenofibrate Capsules, USP 200 mg, distributed nationwide in the US. The recall was initiated on 28 May 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0611-2026
- FDA event ID
- 99130
- Recalling firm
- Ajanta Pharma USA, Bridgewater, NJ
- Brand
- Fenofibrate
- Manufacturer
- Ajanta Pharma USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 May 2026
- FDA classified
- 22 Jun 2026
- Reported
- 1 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Cholesterol Medication
Timeline
| 28 May 2026 | Recall initiated by company | |
| 22 Jun 2026 | Classified by FDA | +25 days |
| 1 Jul 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot # PA02216; Exp. 12/2029
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ajanta Pharma USA
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranolazine Extended-Release Tablets, 1000 mg recalledRanolazine | Ajanta Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Fluphenazine Hydrochloride Tablets, USP, 1mg recalledFluphenazine Hydrochloride | Ajanta Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Aripiprazole Tablets recalled by Ajanta Pharma USAAripiprazole | Ajanta Pharma USA | Packaging Defects | Nationwide |
Other Fenofibrate recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fenofibrate Capsules 67 mg recalled by Glenmark PharmaceuticalsFenofibrate | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Fenofibrate Capsules, Ups 67mg recalled by Cardinal HealthFenofibrate | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS III | Fenofibrate Tablets, USP 145 mg recalled by Hetero Labs, Ltd. - Unit IIIFenofibrate | Hetero Labs Ltd. - Unit III | Other | IN, LA |
| Drug | CLASS II | Fenofibrate, Tablet, 54 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Fenofibrate, Tablet, 54 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |