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.
What this means for you
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.
Related recalls
Same brand · BUPRENORPHINE HYDROCHLORIDE
- HighBuprenorphine injection vials show crystallization identified as buprenorphine free base
FDA (Drugs) · 2026-06-24
- HighBuprenorphine Injection Recalled Due to Incomplete Seal Integrity Issue
FDA (Drugs) · 2024-07-03
- ModerateBuprenorphine HCl Injection Recalled for Crystallization Defect
FDA (Drugs) · 2023-11-15
- ModerateHikma Recalls Buprenorphine Hydrochloride Injection Due to Low Potency
FDA (Drugs) · 2020-09-02
- ModeratePAR Sterile Products Recalls Buprenorphine Hydrochloride Injection Due to Crystallization
FDA (Drugs) · 2017-05-17
Same manufacturer · ENDO USA, Inc.
See all →- ModerateEverolimus 7.5 mg tablets recalled after an out of specification impurity result
FDA (Drugs) · 2025-11-05
- ModerateEverolimus tablets recalled after an out of specification impurity result
FDA (Drugs) · 2025-11-05
- ModerateEverolimus 2.5 mg tablets recalled after an out of specification impurity result
FDA (Drugs) · 2025-11-05
- ModerateEverolimus 10 mg tablets recalled after an out of specification impurity result
FDA (Drugs) · 2025-11-05
- ModerateEverolimus tablets recalled for out of specification impurity in one lot
FDA (Drugs) · 2025-10-22
Same hazard · particulate matter
See all →- SevereACTHAR Gel Recalled for Presence of Glass and Stopper Particulate Matter
FDA (Drugs) · 2026-09-02
- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- CriticalAmerican Regent Recalls Papaverine Hydrochloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Nitroglycerin Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Cyanocobalamin Injections Due to Particulate Matter
FDA (Drugs) · 2026-08-26