Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91
Reported: October 22, 2025 Initiated: September 5, 2025 #D-0026-2026
Product Description
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Details
- Recalling Firm
- Endo USA, Inc.
- Units Affected
- 1,041 cartons
- Distribution
- Nationwide within the United States
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91. Recalled by Endo USA, Inc.. Units affected: 1,041 cartons.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 22, 2025. Severity: Low. Recall number: D-0026-2026.
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