The Recall Desk
ModerateFDA (Drugs)·D-0141-2026·Announced 2025-11-05

Everolimus 10 mg tablets recalled after an out of specification impurity result

Endo USA is recalling 935 cartons of Everolimus tablets 10 mg after results came back out of specification for impurity IP-C.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the FDA designated this Class III and the record cites a specification failure with no stated health consequence.

Plain-English summary

Everolimus tablets, 10 mg, in 28-tablet cartons containing four blister strips of seven tablets, manufactured by Par Pharmaceutical of Chestnut Ridge, New York, are being recalled for failed impurities and degradation specifications.

The product was out of specification for impurity IP-C.

The recall covers 935 cartons from lot 550162801 (which expired November 2025) and lot 550169801 (expiring January 2026), carrying NDC 49884-128-91. The product was distributed nationwide in the United States. The FDA has classified the recall as Class III, its least serious category.

The enforcement record names the impurity specification failure without describing a health consequence, and reports no injuries. Everolimus is a prescription medicine, so patients holding an affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.

The recalled product

Product
Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91
Manufacturer
Endo USA, Inc.
Category
Drug — Immunosuppressant
Hazard
Affected units
935

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: 550162801
  • Exp. Date NOV-25
  • 550169801
  • Exp. Date JAN-26

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Endo USA, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Endo USA, Inc.

See all →

Same hazard · impurity

See all →