Reported Oct 7, 2026 · Ongoing · Updated Oct 13, 2026
Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA,…
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 Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials
- Manufactured forEndo USA, Malvern, PA, NDC 42023-179-05
- Lot codes and dates
Lot#:83912Exp Date 10/2026 Lot#:84234Exp Date 11/2026 Lot#:84990Exp Date 11/2026 Lot#:85003Exp Date 12/2026 Lot#:86443Exp Date 01/2027 Lot#:89909Exp Date 05/2027
- Amount recalled
- 154210 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Crystallization
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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