# FDA recall D-0446-2026

> **Teva Pharmaceuticals USA, Inc** · Class II · drug recall initiated 2026-01-12.

## Product

Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).

## Reason for recall

Superpotent and Subpotent

## Distribution

FL, OH, PR & MS

## Key facts

- **Recall number:** D-0446-2026
- **Recalling firm:** Teva Pharmaceuticals USA, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-01-12
- **Report date:** 2026-04-15

- **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-0446-2026

## Citation

> AI Analytics. FDA recall D-0446-2026. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0446-2026. Source: US FDA. Licensed CC0.

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