Drug recall D-0527-2026

Class II Ongoing reported May 20, 2026

Product

Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.

Reason for recall

Crystallization; identified as Buprenorphine free base

Lots and codes

Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027

Recall details

Recalling firm
ENDO USA, Inc., Rochester, MI
Quantity
34,293 vials
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
March 13, 2026

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