Fenofibrate 67mg Capsules Recalled for Manufacturing Practice Deviations
Glenmark Pharmaceuticals is recalling Fenofibrate 67mg capsules distributed nationwide due to manufacturing process deviations. The recall affects lots 17230834 and 17230835 with expiration dates of March 2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this recall as Class II. The recall is for CGMP deviations without specification of a particular product defect, qualifying as a theoretical risk-of-harm to product integrity without reported injury, meeting criteria for High severity.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA has initiated a nationwide recall of Fenofibrate 67mg capsules due to current good manufacturing practice (CGMP) deviations identified in the manufacturing process.
The recall affects Fenofibrate Capsules 67mg in 100-count bottles with lot numbers 17230834 and 17230835, both with expiration dates of March 2025. The NDC numbers involved are 68462-580-01, 68462-581-01, and 68462-582-01. The product was distributed nationwide in the United States.
The firm initiated the recall on March 13, 2025, and the FDA classified it as a Class II recall on April 8, 2025. This is a voluntary, firm-initiated recall.
Patients taking this medication should contact their healthcare provider or pharmacist for instructions. Consumers should not stop taking their medication without consulting their healthcare provider. Patients who have unused product from the affected lots should return it to their pharmacy.
The recalled product
- Product
- FENOFIBRATE (FENOFIBRATE)
- Brand
- FENOFIBRATE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- cgmp-deviation
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.
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