# FDA recall D-0007-2026

> **AvKARE** · Class II · drug recall initiated 2025-09-02.

## Product

Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only,  Manufactured for AvKARE, Pulaski, TN 38478.  Carton NDC:  42291-565-84; Blister NDC:  42291-565-28

## Reason for recall

Failed Content Uniformity Specifications

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0007-2026
- **Recalling firm:** AvKARE
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-09-02
- **Report date:** 2025-10-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0007-2026

## Citation

> AI Analytics. FDA recall D-0007-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/D-0007-2026. Source: US FDA. Licensed CC0.

---

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