Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Buprenorphine HCl Injection Recalled by Hikma Pharmaceuticals USA Inc. Due to Sub-potent Drug: Out-of-Specification assay results found at 3...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hikma Pharmaceuticals USA Inc. directly.
Affected Products
Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc., NDC: 0143-9246-01.
Quantity: 97,890 vials
Why Was This Recalled?
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hikma Pharmaceuticals USA Inc.
Hikma Pharmaceuticals USA Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report