# FDA recall D-0399-2026

> **MYLAN PHARMACEUTICALS INC** · Class II · drug recall initiated 2026-02-24.

## Product

Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0399-2026
- **Recalling firm:** MYLAN PHARMACEUTICALS INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-02-24
- **Report date:** 2026-03-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgantown, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0399-2026

## Citation

> AI Analytics. FDA recall D-0399-2026. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0399-2026. Source: US FDA. Licensed CC0.

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