# FDA recall D-0543-2026

> **ANI Pharmaceuticals, Inc.** · Class II · drug recall initiated 2026-05-12.

## Product

Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.  NDC 70954-531-20

## Reason for recall

Defective Container; packets were found to be either empty or partially full.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0543-2026
- **Recalling firm:** ANI Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-05-12
- **Report date:** 2026-05-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Baudette, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0543-2026

## Citation

> MORVS. FDA recall D-0543-2026. Retrieved 2026-10-15 from https://api.morvs.ai/recall/D-0543-2026. Source: US FDA. Licensed CC0.

---

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