Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intr
Summary
The FDA issued a Class II for Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Ca by Par Health USA, LLC. Reason: Crystallization; identified as Buprenorphine free base.
Details
Source
Drug Recall
External ID
D-0596-2026
Action Date
2026-06-24
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
Quantity Affected: 46,334 units
Reason for Recall
Crystallization; identified as Buprenorphine free base
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-12
Company
Rochester, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Par Health USA, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Par Health USA, LLC have FDA actions?
This is the only FDA action we have on record for Par Health USA, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0596-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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