Buprenorphine Hydrochloride recall
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Why was Buprenorphine Hydrochloride recalled?
Crystallization; identified as Buprenorphine free base
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
- Product
- Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
- Recalling firm
- ENDO USA, Inc.
- Quantity
- 34,293 vials
- Distribution
- USA Nationwide
- Recall date
- May 20, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)