# FDA recall D-0227-2026

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2025-11-05.

## 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

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0227-2026
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-11-05
- **Report date:** 2025-12-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Naples, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0227-2026

## Citation

> AI Analytics. FDA recall D-0227-2026. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0227-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*