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Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each),...

FDA Recall #D-0140-2026 — Class III — October 10, 2025

Recall #D-0140-2026 Date: October 10, 2025 Classification: Class III Status: Ongoing

Product Description

Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91

Reason for Recall

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

Recalling Firm

Endo USA, Inc. — Malvern, PA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

1,866 cartons

Distribution

Nationwide within the United States

Code Information

Lot #: 550167301, 550167401, Exp. Date NOV-25; 550185101, Exp. Date MAR-26; 550205701, Exp. Date JUL-26

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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