# FDA recall D-0522-2022

> **Teva Pharmaceuticals USA** · Class III · drug recall initiated 2022-01-07.

## Product

Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-42

## Reason for recall

Mislabeling

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0522-2022
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-01-07
- **Report date:** 2022-02-09
- **Termination date:** 2023-06-01

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0522-2022

## Citation

> AI Analytics. FDA recall D-0522-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0522-2022. Source: US FDA. Licensed CC0.

---

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