CLASS II ONGOING Drug recall · Reported 7 Oct 2026 · FDA Enforcement Report
Buprenorphine Hydrochloride, Injection 0.3 mg/mL recalled
Par Health USA is recalling Buprenorphine Hydrochloride, Injection 0.3 mg/mL, distributed nationwide in the US. The recall was initiated on 8 Sep 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0876-2026
- FDA event ID
- 99902
- Recalling firm
- Par Health USA, Rochester, MI
- Manufacturer
- Par Health USA, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Sep 2026
- FDA classified
- 29 Sep 2026
- Reported
- 7 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Sep 2026 | Recall initiated by company | |
| 29 Sep 2026 | Classified by FDA | +21 days |
| 7 Oct 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Crystallization
Product as listed by the FDA
Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Crystallization
Which lots are affected?
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
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Par Health USA
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Buprenorphine HCl, CIII, Injection, 0.3 mg/mL recalled by Par Health USABuprenorphine Hydrochloride | Par Health USA | Other | Nationwide |
Other Buprenorphine recalls
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Buprenorphine HCl, CIII, Injection, 0.3 mg/mL recalled by Par Health USABuprenorphine Hydrochloride | Par Health USA | Other | Nationwide |
| Drug | CLASS II | Buprenorphine Hydrochloride, Injection, 0.3mg/mL recalled by Endo UsaBuprenorphine Hydrochloride | Endo USA | Other | Nationwide |
| Drug | CLASS II | Buprenorphine Hydrochloride Injection recalled by PfizerBuprenorphine Hydrochloride | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Buprenorphine HCl, Injection, 0.3mg/mL recalled by PAR Sterile ProductsBuprenorphine Hydrochloride | PAR Sterile Products | Packaging Defects | Nationwide |