D-0227-2026 Class II Ongoing
FDA drug recall D-0227-2026 was initiated by Lupin Pharmaceuticals Inc. on November 5, 2025 and is designated Class II. Reason for recall: Defective container - seal not adhering to bottles The recall status is ongoing. Affected quantity: 52,128 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 17, 2025
- Initiation Date
- November 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52,128 bottles
Product Description
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Reason for Recall
Defective container - seal not adhering to bottles
Distribution Pattern
Nationwide.
Code Information
Lot # QB00865, exp. date Feb 2028