Buprenorphine Hydrochloride Injection Recall Due to Particulate Matter
Endo USA, Inc. is recalling Buprenorphine Hydrochloride injection vials distributed nationwide due to the presence of particulate matter identified as Buprenorphine free base. The FDA classified this as a Class II recall.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a drug product defect. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a manufacturing defect (particulate matter) rather than a high-risk pathogen or acute safety threat, making this a moderate-severity recall.
Plain-English summary
Endo USA, Inc. is recalling Buprenorphine Hydrochloride Injection, 0.3mg/mL, 5x1 mL Single Dose Vials (NDC 42023-179-05) distributed nationwide. The recall affects Lot #84132 (expiration 02/28/2027) and Lot #87693 (expiration 03/31/2027), totaling 34,293 vials.
The product is being recalled because particulate matter identified as Buprenorphine free base has been identified in the vials. Buprenorphine Hydrochloride is a prescription opioid medication administered by intramuscular or intravenous injection.
Healthcare providers and patients who have received vials from the affected lots should discontinue use and contact Endo USA, Inc. Patients should consult their healthcare provider about alternative treatment options.
The recalled product
- Product
- BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
- Brand
- BUPRENORPHINE HYDROCHLORIDE
- Manufacturer
- ENDO USA, Inc.
- Category
- Drug — Injectable / Opioid
- Affected units
- 34,293
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 #: 84132
- Exp 02/28/2027
- 87693
- Exp 03/31/2027
Distribution
Distributed nationwide across the United States.
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Similar recalls
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FDA (Drugs) · 2026-10-07
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