FDA Drug recall D-0227-2026
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108,…
- FDA Drug
- Class II
- ongoing
- Published 2025-12-17
On 2025-12-17 the FDA classified a Class II recall of Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108,… by Lupin Pharmaceuticals, citing defective container - seal not adhering to bottles.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0227-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-05 |
| Published | 2025-12-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
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
Defective container - seal not adhering to bottles
Identifiers
| ndc | 68180-351-08 |
|---|---|
| ndc | 68180-351-06 |
| ndc | 68180-351-09 |
| ndc | 68180-351-03 |
| ndc | 68180-351-01 |
| ndc | 68180-352-11 |
| ndc | 68180-352-01 |
| ndc | 68180-352-03 |
| ndc | 68180-352-06 |
| ndc | 68180-352-09 |
| ndc | 68180-352-02 |
| ndc | 68180-352-05 |
| ndc | 68180-353-11 |
| ndc | 68180-353-01 |
| ndc | 68180-353-03 |
| ndc | 68180-353-02 |
| ndc | 68180-353-06 |
| ndc | 68180-353-09 |
| ndc | 68180-353-05 |
| ndc | 68180-978-01 |
| ndc | 68180-978-02 |
| ndc | 68180-978-03 |
| ndc | 68180-986-04 |
| ndc | 68180-986-02 |
| ndc | 68180-986-01 |
| ndc | 68180-986-03 |
| ndc | 68180-992-04 |
| ndc | 68180-992-01 |
| ndc | 68180-992-02 |
| ndc | 68180-992-03 |
| code_info | Lot # QB00865, exp. date Feb 2028 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2025-12-17 · Lupin Pharmaceuticals
All Lupin Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0227-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.