CLASS II ONGOING Drug recall · Reported 17 Dec 2025 · FDA Enforcement Report
Sertraline Hydrochloride Tablets USP, 100 mg recalled
Lupin Pharmaceuticals is recalling Sertraline Hydrochloride Tablets USP, 100 mg, distributed nationwide in the US. The recall was initiated on 5 Nov 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0227-2026
- FDA event ID
- 97936
- Recalling firm
- Lupin Pharmaceuticals, Naples, FL
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Nov 2025
- FDA classified
- 10 Dec 2025
- Reported
- 17 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Antidepressants
Timeline
| 5 Nov 2025 | Recall initiated by company | |
| 10 Dec 2025 | Classified by FDA | +35 days |
| 17 Dec 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container - seal not adhering to bottles
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Defective container - seal not adhering to bottles
Which lots are affected?
Lot # QB00865, exp. date Feb 2028
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Sertraline recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sertraline Tablets, USP 100 mg recalled by Legacy PharmaceuticalSertraline Hydrochloride | Legacy Pharmaceutical Packaging | Manufacturing (CGMP) Deviations | AR, CA |
| Drug | CLASS II | sertraline HCl tablets, 25 mg recalled by Greenstone | Greenstone | Other | Nationwide |
| Drug | CLASS II | Sertraline HCL Tablet, 50 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |