Sertraline Hydrochloride Tablets USP — Class II drug recall D-0227-2026
Ongoing recall by Lupin Pharmaceuticals Inc., reported 2025-12-17, distributed nationwide. Defective container - seal not adhering to bottles
| Recall number | D-0227-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Naples, FL, United States |
| Recall initiated | 2025-11-05 |
| Classified | 2025-12-10 |
| Reported by FDA | 2025-12-17 |
| Distributed | Nationwide (US) |
| Quantity | 52,128 bottles |
| Reason classes | packaging |
| NDC | 68180-0351, 68180-0351-01, 68180-0351-03, 68180-0351-06, 68180-0351-08, 68180-0351-09, 68180-0352, 68180-0352-01, 68180-0352-02, 68180-0352-03, 68180-0352-05, 68180-0352-06, 68180-0352-09, 68180-0352-11, 68180-0353, 68180-0353-01, 68180-0353-02, 68180-0353-03, 68180-0353-05, 68180-0353-06, 68180-0353-09, 68180-0353-11, 68180-0978, 68180-0978-01, 68180-0978-02 and 11 more |
| Lot numbers | QB00865 |
| Expiration dates | 2028-02-20 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0227-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.