Why it was recalled
Crystallization; identified as Buprenorphine free base
Product 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.
Lot numbers, UPCs & expiration codes
Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0527-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 13, 2026
- FDA report date
- May 20, 2026
- Quantity
- 34,293 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ENDO USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0527-2026, exactly as published.
Show all FDA fields
- City
- Rochester
- State
- MI
- Status
- Ongoing
- Country
- United States
- Event ID
- 98610
- Address
- 870 Parkdale Rd
- Code information
- Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
- Postal code
- 48307-1740
- Report date
- May 20, 2026
- Product type
- Drugs
- Recall number
- D-0527-2026
- Classification
- Class II
- Recalling firm
- ENDO USA, Inc.
- Product quantity
- 34,293 vials
- Reason for recall
- Crystallization; identified as Buprenorphine free base
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Mar 13, 2026
- Initial firm notification
- Letter
- Center classification date
- May 11, 2026