Drug FDA Class II Ongoing cGMP deviation

Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.

ENDO USA, Inc. Published May 20, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact ENDO USA, Inc. or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Crystallization; identified as Buprenorphine free base

Hazards

Buprenorphine Free Base Crystallization · primary

Affected products (1)

Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.

BUPRENORPHINE HYDROCHLORIDE · 34,293 vials

NDC: 42023-179, 42023-179-05

Code info: Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027

Affected areas

Nationwide

Timeline

Initiated

Mar 13, 2026
Published

May 20, 2026

Recall number: D-0527-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.