# FDA recall D-0141-2026

> **Endo USA, Inc.** · Class III · drug recall initiated 2025-10-10.

## Product

Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0141-2026
- **Recalling firm:** Endo USA, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-10
- **Report date:** 2025-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0141-2026

## Citation

> AI Analytics. FDA recall D-0141-2026. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0141-2026. Source: US FDA. Licensed CC0.

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