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: November 5, 2025 Initiated: October 10, 2025 #D-0139-2026
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
- 6,655 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: 6,655 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 November 5, 2025. Severity: Low. Recall number: D-0139-2026.
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