Endo USA recalls 5x1mL Buprenorphine injections due to crystallization risk. Affected lots expire 02/2027 and 03/2027. Contact for return instructions.
Crystallization; identified as Buprenorphine free base
Endo USA is recalling specific buprenorphine injection vials that may crystallize, potentially causing safety issues. This recall affects prescription-only medication with specific lot numbers and expiration dates.
The buprenorphine may crystallize in the vial, which could lead to inconsistent drug delivery or potential safety issues when administered. This crystallization is identified as buprenorphine free base.
Prescription patients using Endo USA's buprenorphine injections with lot numbers 84132 or 87693 are affected. Those with the specific expiration dates (02/2027 or 03/2027) are at risk.
Check for vials labeled 'Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only' with lot numbers 84132 or 87693. The expiration dates are 02/28/2027 or 03/31/2027.
Look for lot numbers 84132 or 87693 on the vial label with expiration dates 02/28/2027 or 03/31/2027.
The buprenorphine may crystallize, identified as buprenorphine free base, which could lead to inconsistent drug delivery or safety issues.
Check for vials labeled 'Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only' with lot numbers 84132 or 87693 and expiration dates 02/28/2027 or 03/31/2027.
The recall record does not specify a remedy, so contact Endo USA for instructions.
We’ve drafted a message you can send Endo USA to request your refund or repair — edit it as you like.
Subject: Recall D-0527-2026 — Endo USA Endo USA Hello, I own a Endo USA that is covered by recall D-0527-2026 from Endo USA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
