FDA-Drug2026-06-24Class IIPROCESSING DEFECT
Par Health USA buprenorphine injection recalled for crystallization
OTHERNationwide distribution
Par Health USA buprenorphine injection recalled for crystallization
Par Health USA's buprenorphine HCl injection (0.3 mg/mL) has been found to contain crystallization identified as buprenorphine free base in certain lots. This affects vials distributed nationwide. The FDA has classified this as a Class II recall.
- Check if you have buprenorphine from Par Health USA with lot #82886 (expiration 09/30/2026) or lot #89646 (expiration 05/31/2027).
- Do not use affected vials.
- Contact your pharmacy or healthcare provider for guidance on replacement or alternative medication.
Hazard
Crystallization; identified as Buprenorphine free base
Sold states
Nationwide in the USA.
Affected count
46,334 units
Manufactured in
870 Parkdale Rd, Rochester, MI, United States
Products
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 for: Endo USA, Malvern, PA 19355, NDC 42023-179-05
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0596-2026Don't want to check this manually?
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