FDA-Drug2026-05-20Class IIPROCESSING DEFECT
Endo USA buprenorphine injection recalled for particulate matter contamination
Nationwide distribution
Endo USA buprenorphine injection recalled for particulate matter
Endo USA is recalling certain batches of buprenorphine hydrochloride 0.3 mg/mL injection due to the presence of particulate matter identified as buprenorphine free base in the vials. The affected lots are 84132 (expiration 02/28/2027) and 87693 (expiration 03/31/2027). No injuries have been reported.
- Check your buprenorphine vials against the lot numbers and expiration dates listed in this recall.
- Do not use vials from lot 84132 or 87693.
- Contact your pharmacy or healthcare provider for a replacement or alternative.
- Report any use of recalled product to the FDA MedWatch program or your healthcare provider.
Hazard
Presence of particulate matter: identified as Buprenorphine free base
Sold states
USA Nationwide
Affected count
34,293 vials
Manufactured in
870 Parkdale Rd, Rochester, MI, United States
Products
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0527-2026Don't want to check this manually?
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