FDA Recall D-0227-2026
Lupin Pharmaceuticals Inc. · Naples, FL
Class II Ongoing 190 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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
Recall record
- Recall number
D-0227-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide.
- Recall initiated
- 2025-11-05
- Classified by FDA Center
- 2025-12-10
- FDA published
- 2025-12-17
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Firm location
- Naples, FL
Drug identification
- Brand name(s)
- SERTRALINE HYDROCHLORIDE
- Generic name(s)
- SERTRALINE HYDROCHLORIDE
- Manufacturer(s)
- Lupin Pharmaceuticals, Inc.
- NDC(s)
68180-351, 68180-352, 68180-353, 68180-978, 68180-986, 68180-992- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.