Drug FDA Class III Ongoing Failed specifications

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

Endo USA, Inc. Published Nov 5, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Endo USA, Inc. or your place of purchase with questions, and see the source record below for full details.

Reason for recall

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

Hazards

Impurity IP-C · primary

Affected products (1)

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

EVEROLIMUS · 1,866 cartons

NDC: 49884-119, 49884-125, 49884-127, 49884-128, 49884-119-52, 49884-119-91, 49884-125-52, 49884-125-91, 49884-127-52, 49884-127-91, 49884-128-52, 49884-128-91

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

Affected areas

Nationwide

Timeline

Initiated

Oct 10, 2025
Published

Nov 5, 2025

Recall number: D-0140-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.