# FDA recall D-0913-2023

> **Teva Pharmaceuticals USA Inc** · Class II · drug recall initiated 2023-07-05.

## Product

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ  07054, NDC 0093-8199-28

## Reason for recall

Failed Moisture Limits: Water (moisture) content above the approved product specifications.

## Distribution

Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.

## Key facts

- **Recall number:** D-0913-2023
- **Recalling firm:** Teva Pharmaceuticals USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-07-05
- **Report date:** 2023-07-19
- **Termination date:** 2024-01-10

- **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-0913-2023

## Citation

> AI Analytics. FDA recall D-0913-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0913-2023. Source: US FDA. Licensed CC0.

---

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