Par Health Recalls Buprenorphine Hydrochloride Injection Due to Crystallization
Par Health USA is voluntarily recalling 154,210 bottles of Buprenorphine Hydrochloride Injection due to crystallization. The FDA classifies this as a Class II recall.
What this means for you
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences are assigned a severity score of 4 (Severe), as the agency classification prevents a score lower than 4.
Plain-English summary
Par Health USA, LLC is voluntarily recalling 154,210 bottles of Buprenorphine Hydrochloride Injection, 0.3 mg/mL. The product is distributed in 5 x 1 mL single-dose vials and is manufactured for Endo USA. The recall was initiated on September 8, 2026, due to crystallization in the product.
The FDA has classified this recall as Class II, which indicates a situation that may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The affected lots are 83912, 84234, 84990, 85003, 86443, and 89909, with expiration dates ranging from October 2026 to May 2027.
The product was distributed nationwide in the United States. Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
- Brand
- BUPRENORPHINE HYDROCHLORIDE
- Manufacturer
- Par Health USA, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 154,210
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 (7)
- Lot#:83912
- Exp Date 10/2026 Lot#:84234
- Exp Date 11/2026 Lot#:84990
- Exp Date 11/2026 Lot#:85003
- Exp Date 12/2026 Lot#:86443
- Exp Date 01/2027 Lot#:89909
- Exp Date 05/2027
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
- ModerateBuprenorphine Hydrochloride Injection Recall Due to Particulate Matter
FDA (Drugs) · 2026-05-20
- 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
Same hazard · crystallization
See all →- ModerateCyproheptadine Hydrochloride Syrup Recall Due to Precipitate
FDA (Drugs) · 2026-07-29
- ModerateDapsone Gel Recalled Nationwide for Crystallization
FDA (Drugs) · 2025-01-08
- HighDapsone Topical Gel Recalled Due to Crystallization Defect
FDA (Drugs) · 2025-01-08
- ModerateOTC cough and congestion medication recalled for crystallization
FDA (Drugs) · 2024-11-13
- LowOTC Cold and Cough Medication Recalled Due to Crystallization
FDA (Drugs) · 2024-11-13