FDA Recall D-0141-2026

Endo USA, Inc. · Malvern, PA

Class III Ongoing 216 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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

Lot / code: Lot #: 550162801, Exp. Date NOV-25; 550169801, Exp. Date JAN-26

Quantity: 935 cartons

Reason for recall

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

Recall record

Recall number: D-0141-2026
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2025-10-10
Classified by FDA Center: 2025-10-29
FDA published: 2025-11-05
Recalling firm: Endo USA, Inc.
Firm location: Malvern, PA

Drug identification

Brand name(s): EVEROLIMUS
Generic name(s): EVEROLIMUS
Manufacturer(s): Par Health USA, LLC
NDC(s): 49884-119, 49884-125, 49884-127, 49884-128
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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