Reported May 20, 2026 · Ongoing
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA,…
ENDO USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ENDO USA, Inc. · 870 Parkdale Rd · Rochester, MI · 48307-1740
Is this the product you have?
- Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only
- Manufactured forEndo USA, Malvern, PA 19855, NDC 42023-179-05
- Lot codes and dates
Lot #: 84132Exp 02/28/202787693Exp 03/31/2027
- Amount recalled
- 34,293 vials
Where it was sold
- Nationwide
Why it was recalled
Crystallization; identified as Buprenorphine free base
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new ENDO USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.