D-0227-2026 Class II Ongoing
FDA drug recall D-0227-2026 was initiated by Lupin Pharmaceuticals Inc. on Nov 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
- Dec 17, 2025
- Initiation Date
- Nov 5, 2025
- 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0227-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026