Reported Jun 24, 2026 · Ongoing
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or…
Par Health USA, LLC
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: Par Health USA, LLC · 870 Parkdale Rd · Rochester, MI · 48307-1740
Is this the product you have?
- Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use
- Manufactured forEndo USA, Malvern, PA 19355, NDC 42023-179-05
- Lot codes and dates
Lot #: 82886exp 09/30/202689646exp 05/31/2027
- Amount recalled
- 46,334 units
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 Par Health USA, LLC 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.