CLASS II ONGOING Drug recall · Reported 20 May 2026 · FDA Enforcement Report
Buprenorphine Hydrochloride, Injection, 0.3mg/mL recalled by Endo Usa
Endo USA is recalling Buprenorphine Hydrochloride, Injection, 0.3mg/mL, mL Single Dose Vials, distributed nationwide in the US. The recall was initiated on 13 Mar 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-0527-2026
- FDA event ID
- 98610
- Recalling firm
- Endo USA, Rochester, MI
- Manufacturer
- Par Health USA, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Mar 2026
- FDA classified
- 11 May 2026
- Reported
- 20 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 13 Mar 2026 | Recall initiated by company | |
| 11 May 2026 | Classified by FDA | +59 days |
| 20 May 2026 | Published in enforcement report | +9 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 Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Crystallization; identified as Buprenorphine free base
Which lots are affected?
Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
Where was it sold?
USA 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 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 Endo USA
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Everolimus tablets 5mg (each carton contains 4 blister recalled | Endo USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Everolimus tablets 10 mg (each carton contains 4 blister recalled | Endo USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Everolimus tablets 2.5 mg (each carton contains 4 blister recalled | Endo USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Everolimus tablets 7.5mg (each carton contains 4 blister recalled | Endo USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Everolimus tablets 5mg (each carton contains 4 blister recalled | Endo USA | Potency & Assay | Nationwide |
Other Buprenorphine recalls
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Buprenorphine Hydrochloride, Injection 0.3 mg/mL recalledBuprenorphine Hydrochloride | Par Health USA | Other | Nationwide |
| 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 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 |