Why it was recalled
Crystallization; identified as Buprenorphine free base
Product description
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05
Lot numbers, UPCs & expiration codes
Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
Where it was sold
Nationwide in the USA.
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-0596-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 12, 2026
- FDA report date
- Jun 24, 2026
- Quantity
- 46,334 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Par Health USA, LLC
Original FDA data
Every field from FDA enforcement report D-0596-2026, exactly as published.
Show all FDA fields
- City
- Rochester
- State
- MI
- Status
- Ongoing
- Country
- United States
- Event ID
- 99237
- Address
- 870 Parkdale Rd
- Code information
- Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
- Postal code
- 48307-1740
- Report date
- Jun 24, 2026
- Product type
- Drugs
- Recall number
- D-0596-2026
- Classification
- Class II
- Recalling firm
- Par Health USA, LLC
- Product quantity
- 46,334 units
- Reason for recall
- Crystallization; identified as Buprenorphine free base
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jun 12, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 17, 2026