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

Crystallization; identified as Buprenorphine free base

Class II Medicine & devices FDA May 20, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
ENDO USA, Inc. — Rochester, MI
Severity
Class II — moderate
Reported
May 20, 2026
Quantity
34,293 vials
Recall number
D-0527-2026
Status
Ongoing
Source
FDA

Where it went

USA Nationwide

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