Fenofibrate Capsules 200 mg Recalled for CGMP Manufacturing Deviations
Ajanta Pharma USA Inc. is recalling Fenofibrate Capsules, USP 200 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during production. The recall affects 3,648 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class II recall with CGMP deviations cited as the reason. The source text does not report any illnesses, injuries, or hospitalizations. CGMP deviations are manufacturing compliance issues that represent potential but not confirmed safety risks, warranting a Moderate classification per the rubric for low-risk contamination and precautionary recalls.
Plain-English summary
Ajanta Pharma USA Inc., located in Bridgewater, New Jersey, is voluntarily recalling Fenofibrate Capsules, USP 200 mg (100 capsule bottles). The recall was initiated on May 28, 2026, in response to Current Good Manufacturing Practice (CGMP) deviations discovered in manufacturing.
The affected product is identified by Lot # PA02216 with an expiration date of 12/2029. Approximately 3,648 bottles have been distributed nationwide under NDC 27241-120-04.
Consumers taking this medication should contact their healthcare provider or pharmacist about their treatment options. Do not abruptly stop taking prescribed fenofibrate without consulting a healthcare provider, as doing so may affect your medical condition.
The recalled product
- Product
- FENOFIBRATE (FENOFIBRATE)
- Brand
- FENOFIBRATE
- Manufacturer
- Ajanta Pharma USA Inc
- Affected units
- 3,648
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # PA02216
- Exp. 12/2029
UPCs (3)
- 0327241119040
- 0327241118043
- 0327241120046
Distribution
Distributed nationwide across the United States.
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