Medications & Supplements/Prescription Drugs

Everolimus Tablets Recalled for Impurity Out-of-Specification

Agency Publication Date: October 29, 2025

Summary

Endo USA, Inc. is voluntarily recalling 11,491 cartons of Everolimus tablets in 2.5 mg, 5 mg, 7.5 mg, and 10 mg strengths because they failed stability testing. The tablets were found to have levels of a degradation impurity, known as IP-C, that exceed the approved specifications. The affected medication was manufactured by Par Pharmaceutical and distributed nationwide across the United States between late 2025 and 2026.

Risk

The product exceeded the allowed limits for a specific degradation impurity (IP-C), which could potentially affect the quality or purity of the medication over time. No specific injuries or adverse health consequences have been reported to date for this recall.

What You Should Do

Check your medication packaging for Everolimus tablets in 2.5 mg, 5 mg, 7.5 mg, or 10 mg strengths to see if the lot numbers or expiration dates match the affected products.
Identify the affected products by checking the lot number and expiration date printed on the carton or blister strips. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse effects.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Everolimus tablets 5mg, 28 tabletsby Endo USA, Inc.

Variants: 5mg strength, 28 tablets per carton, 4 blister strips with 7 tablets each

Lot Numbers:

550184901 (Exp. MAR-26)

550185001 (Exp. MAR-26)

550189901 (Exp. APR-26)

550190001 (Exp. APR-26)

550203901 (Exp. Jul-26)

550205601 (Exp. Jul-26)

NDC:

49884-125-91

Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977

Product: Everolimus tablets 7.5mg, 28 tabletsby Endo USA, Inc.

Variants: 7.5mg strength, 28 tablets per carton, 4 blister strips with 7 tablets each

Lot Numbers:

550167301 (Exp. NOV-25)

550167401 (Exp. NOV-25)

550185101 (Exp. MAR-26)

550205701 (Exp. JUL-26)

NDC:

49884-127-91

Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977

Product: Everolimus tablets 10 mg, 28 tabletsby Endo USA, Inc.

Variants: 10 mg strength, 28 tablets per carton, 4 blister strips with 7 tablets each

Lot Numbers:

550162801 (Exp. NOV-25)

550169801 (Exp. JAN-26)

NDC:

49884-128-91

Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977

Product: Everolimus tablets 2.5 mg, 28 tabletsby Endo USA, Inc.

Variants: 2.5 mg strength, 28 tablets per carton, 4 blister strips with 7 tablets each

Lot Numbers:

550172201 (Exp. JAN-26)

550184801 (Exp. MAR-26)

550204001 (Exp. JUL-26)

NDC:

49884-119-91

Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97866

Status: Active

Manufacturer: Endo USA, Inc.

Sold By: Retail Pharmacies

Manufactured In: United States

Units Affected: 4 products (6,655 cartons; 1,866 cartons; 935 cartons; 2,035 cartons)

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication packaging for Everolimus tablets in 2.5 mg, 5 mg, 7.5 mg, or 10 mg strengths to see if the lot numbers or expiration dates match the affected products.

Identify the affected products by checking the lot number and expiration date printed on the carton or blister strips. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse effects.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Everolimus tablets 5mg, 28 tabletsby Endo USA, Inc.

Variants: 5mg strength, 28 tablets per carton, 4 blister strips with 7 tablets each

Lot Numbers:

550184901 (Exp. MAR-26)

550185001 (Exp. MAR-26)

550189901 (Exp. APR-26)

550190001 (Exp. APR-26)

550203901 (Exp. Jul-26)

550205601 (Exp. Jul-26)

NDC:

49884-125-91

Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977

Product: Everolimus tablets 7.5mg, 28 tabletsby Endo USA, Inc.

Variants: 7.5mg strength, 28 tablets per carton, 4 blister strips with 7 tablets each

Lot Numbers:

550167301 (Exp. NOV-25)

550167401 (Exp. NOV-25)

550185101 (Exp. MAR-26)

550205701 (Exp. JUL-26)

NDC:

49884-127-91

Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977

Product: Everolimus tablets 10 mg, 28 tabletsby Endo USA, Inc.

Variants: 10 mg strength, 28 tablets per carton, 4 blister strips with 7 tablets each

Lot Numbers:

550162801 (Exp. NOV-25)

550169801 (Exp. JAN-26)

NDC:

49884-128-91

Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977

Product: Everolimus tablets 2.5 mg, 28 tabletsby Endo USA, Inc.

Variants: 2.5 mg strength, 28 tablets per carton, 4 blister strips with 7 tablets each

Lot Numbers:

550172201 (Exp. JAN-26)

550184801 (Exp. MAR-26)

550204001 (Exp. JUL-26)

NDC:

49884-119-91

Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977