CLASS II Drug recall · Reported 15 Nov 2023 · FDA Enforcement Report
Buprenorphine HCl, Injection, 0.3mg/mL recalled by PAR Sterile Products
PAR Sterile Products is recalling Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, distributed nationwide in the US. The recall was initiated on 9 Nov 2021 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-0087-2024
- FDA event ID
- 89016
- Recalling firm
- PAR Sterile Products, Rochester, MI
- Manufacturer
- Par Health USA, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Nov 2021
- FDA classified
- 4 Nov 2023
- Reported
- 15 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 9 Nov 2021 | Recall initiated by company | |
| 4 Nov 2023 | Classified by FDA | +725 days |
| 15 Nov 2023 | Published in enforcement report | +11 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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Crystallization; identified as Buprenorphine free base
Which lots are affected?
Lot No: 343716, Exp. Date: 11/2021; Lot No: 350565, Exp. Date: 07/2022; Lot No: 26921, Exp. Date: 07/2022; Lot No: 36227, Exp. Date: 02/2023
Where was it sold?
Nationwide 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.
More recalls from PAR Sterile Products
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Treprostinil Injection, 20 mg/ (1 mg/mL) recalled | Par Sterile Products | Particulate Matter | Nationwide |
| Drug | CLASS II | Vasostrict (vasopressin in 5% Dextrose) Injection per mL) recalledVasostrict | Par Sterile Products | Potency & Assay | Nationwide |
| Drug | CLASS II | Buprenorphine HCI Injection, 0.3 mg/mL Single Dose Vial recalledBuprenorphine Hydrochloride | PAR Sterile Products | Particulate Matter | Nationwide |
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 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 Sublingual Tablets, 8 mg-bottles recalledBuprenorphine | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |