CLASS II ONGOING Drug recall · Reported 24 Jun 2026 · FDA Enforcement Report
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL recalled by Par Health USA
Par Health USA is recalling Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, mL Single Dose Vials per, distributed nationwide in the US. The recall was initiated on 12 Jun 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-0596-2026
- FDA event ID
- 99237
- Recalling firm
- Par Health USA, Rochester, MI
- Manufacturer
- Par Health USA, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Jun 2026
- FDA classified
- 17 Jun 2026
- Reported
- 24 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Jun 2026 | Recall initiated by company | |
| 17 Jun 2026 | Classified by FDA | +5 days |
| 24 Jun 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Crystallization; identified as Buprenorphine free base
Product as listed by the FDA
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Crystallization; identified as Buprenorphine free base
Which lots are affected?
Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
Where was it sold?
Nationwide in the USA.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Buprenorphine recalls
All 22| 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 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 |
| Drug | CLASS II | Buprenorphine Sublingual Tablets, 8 mg-bottles recalledBuprenorphine | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |