# FDA recall D-1304-2022

> **Glenmark Pharmaceuticals Inc., USA** · Class III · drug recall initiated 2022-07-11.

## Product

Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.

## Reason for recall

Defective Container: Tube split from side seam

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1304-2022
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2022-07-11
- **Report date:** 2022-08-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1304-2022

## Citation

> AI Analytics. FDA recall D-1304-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-1304-2022. Source: US FDA. Licensed CC0.

---

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