Buprenorphine Hydrochloride recall (ENDO USA, Inc.)
DrugClass IIOngoing
Summary: ENDO USA, Inc. is recalling 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: Crystallization; identified as Buprenorphine free base.
What is being recalled
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Why
Crystallization; identified as Buprenorphine free base
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
USA Nationwide
How to tell if yours is affected
Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0527-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 13, 2026 |
| Reported | May 20, 2026 |
| Company | ENDO USA, Inc. |
| Company location | Rochester, MI, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 34,293 vials |
More recalls from ENDO USA, Inc. · all drug recalls · recalls from March 2026