Class II
Ongoing
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
This recall is currently active, issued December 17, 2025. It was issued by Lupin Pharmaceuticals Inc..
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- November 5, 2025
- Posted
- December 17, 2025
- Recall Number
- D-0227-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 52,128 bottles
- Firm Location
- Naples, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Defective container - seal not adhering to bottles
Distribution
Nationwide.
Lot / Code Info
Lot # QB00865, exp. date Feb 2028
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