# FDA recall D-0521-2026

> **Teva Pharmaceuticals USA, Inc** · Class II · drug recall initiated 2026-04-06.

## Product

Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin

## Distribution

Nationwide in the USA, Puerto Rico and Virgin Islands

## Key facts

- **Recall number:** D-0521-2026
- **Recalling firm:** Teva Pharmaceuticals USA, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-04-06
- **Report date:** 2026-04-29

- **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-0521-2026

## Citation

> AI Analytics. FDA recall D-0521-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/D-0521-2026. Source: US FDA. Licensed CC0.

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