Fenofibrate Capsules Recalled for CGMP Manufacturing Deviations
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Fenofibrate Capsules 67 mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 100-count 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 recall is FDA Class II for CGMP deviations, a manufacturing/quality control issue. The source text does not report any hospitalizations, illnesses, or injuries; the hazard is procedural non-compliance rather than a direct health threat, consistent with a Moderate severity classification.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Fenofibrate Capsules 67 mg, USP, 100-count bottles, due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing operations. The affected product has NDC# 68462-580-01 and includes Lot #17230834 (expiration Mar-25) and Lot #17230835 (expiration Mar-25).
The product was distributed nationwide in the United States. Fenofibrate is a prescription medication used to treat cholesterol. The manufacturer initiated the recall voluntarily by letter on March 13, 2025, and the FDA classified it as a Class II recall on April 8, 2025.
Patients currently taking this medication should contact their healthcare provider or pharmacist for guidance. Do not stop taking fenofibrate without medical advice. Consult your pharmacist to confirm whether your supply is affected by checking the lot number on your bottle.
The recalled product
- Product
- FENOFIBRATE (FENOFIBRATE)
- Brand
- FENOFIBRATE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
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 (3)
- Lot # 17230834
- exp. date Mar-25 17230835
- exp. date Mar-25
UPCs (1)
- 0368462580011
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 39 products in this recall →Related recalls
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