Buprenorphine injection vials show crystallization identified as buprenorphine free base
Buprenorphine HCl Injection, 0.3 mg/mL single dose vials, is being recalled because of crystallization identified as buprenorphine free base. 46,334 units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where crystalline material has formed in an injectable solution, a risk of harm with no injuries reported in the source.
Plain-English summary
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, five 1 mL single dose vials per carton, prescription only, for intramuscular or intravenous use, manufactured for Endo USA of Malvern, Pennsylvania, NDC 42023-179-05, is being recalled. The action covers 46,334 units.
The stated reason is crystallization, identified as buprenorphine free base. The FDA classified the action as Class II.
Affected lots are 82886, expiring 09/30/2026, and 89646, expiring 05/31/2027. Distribution was nationwide in the USA. The vials are supplied to healthcare providers rather than sold directly to consumers.
Facilities should identify affected stock using the NDC and lot numbers above, quarantine it, and follow the instructions issued by the firm.
The recalled product
- Product
- BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
- Brand
- BUPRENORPHINE HYDROCHLORIDE
- Manufacturer
- Par Health USA, LLC
- Category
- Drug — Injectable analgesic
- Affected units
- 46,334
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 82886
- exp 09/30/2026
- 89646
- exp 05/31/2027
Distribution
Distributed nationwide across the United States.
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