Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
â ď¸ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- ENDO USA, Inc.
- Reason for Recall:
- Crystallization; identified as Buprenorphine free base
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Product Codes/Lot Numbers:
Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0527-2026
Related Recalls
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.