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ENDO USA, Inc. — Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only
Do not stop taking this without speaking to your pharmacist or doctor.
What’s wrong
Crystallization; identified as Buprenorphine free base
The Recall Registry rates this serious — FDA Class II: temporary or medically reversible health harm.
What to do
Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.
Who to contact: Recalling firm: ENDO USA, Inc.
The 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.
Details
- Units affected
- 34,293 vials
- Recall date
- March 13, 2026
- Brand
- ENDO USA, Inc.
USA Nationwide
The official notice
This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.
Their exact wording: “ENDO USA, Inc. — Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.”
Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.
Filed under: Prescription medicine