# FDA recall D-0439-2024

> **Teva Pharmaceuticals USA, Inc** · Class II · drug recall initiated 2024-03-28.

## Product

Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only,  Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054.  Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15

## Reason for recall

Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0439-2024
- **Recalling firm:** Teva Pharmaceuticals USA, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-03-28
- **Report date:** 2024-04-17

- **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-0439-2024

## Citation

> AI Analytics. FDA recall D-0439-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0439-2024. Source: US FDA. Licensed CC0.

---

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