Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq Recalled by Fusion Pharmaceuticals, LLC Due to Microbial Contamination of a Non-Sterile Product: Kit component...
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 Fusion Pharmaceuticals, LLC directly.
Affected Products
DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmaceuticals LLC., 768 Calle Plano, Camarillo, CA 93012. NDC: 43093-104-01.
Quantity: 9,439 Kits
Why Was This Recalled?
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Where Was This Sold?
California
About Fusion Pharmaceuticals, LLC
Fusion Pharmaceuticals, LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report