FDA DrugsClass II
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta...
Published: July 1, 2026Recall ID: D-0611-2026Category: drugsCountry: US
Reason for Recall / Hazard
CGMP Deviations
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Bridgewater |
| State | NJ |
| Openfda › Nui › 1 | N0000175596 |
| Openfda › Nui › 2 | N0000175375 |
| Openfda › Nui › 3 | M0543661 |
| Openfda › Upc › 1 | 0327241119040 |
| Openfda › Upc › 2 | 0327241118043 |
| Openfda › Upc › 3 | 0327241120046 |
| Openfda › Unii | U202363UOS |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 200311 |
| Openfda › Rxcui › 2 | 310288 |
| Openfda › Rxcui › 3 | 310289 |
| Openfda › Spl id | 2dffe879-0f18-4961-b1a9-0d69565a04a6 |
| Openfda › Brand name | FENOFIBRATE |
| Openfda › Spl set id | da2f0ba4-7c16-4fb0-bc1c-45540e8fefbf |
| Openfda › Package ndc › 1 | 27241-118-04 |
| Openfda › Package ndc › 2 | 27241-118-05 |
| Openfda › Package ndc › 3 | 27241-119-04 |
| Openfda › Package ndc › 4 | 27241-119-05 |
| Openfda › Package ndc › 5 | 27241-120-04 |
| Openfda › Package ndc › 6 | 27241-120-05 |
| Openfda › Product ndc › 1 | 27241-118 |
| Openfda › Product ndc › 2 | 27241-119 |
| Openfda › Product ndc › 3 | 27241-120 |
| Openfda › Generic name | FENOFIBRATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class cs | Fibric Acids [CS] |
| Openfda › Substance name | FENOFIBRATE |
| Openfda › Pharm class epc | Peroxisome Proliferator Receptor alpha Agonist [EPC] |
| Openfda › Pharm class moa | Peroxisome Proliferator-activated Receptor alpha Agonists [MoA] |
| Openfda › Manufacturer name | Ajanta Pharma USA Inc. |
| Openfda › Application number | ANDA210705 |
| Openfda › Is original packager | true |
| Event id | 99130 |
| Address 1 | 400 Crossing Blvd Ste 102 |
| Address 2 | N/A |
| Code info | Lot # PA02216; Exp. 12/2029 |
| Postal code | 08807-2863 |
| Report date | 20260701 |
| Product type | Drugs |
| Product quantity | 3648 bottles |
| Reason for recall | CGMP Deviations |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260528 |
| Initial firm notification | N/A |
| Center classification date | 20260622 |
Overview
- Recalling FirmAjanta Pharma USA Inc
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide