Dicopanol FusePaq Kit (Fusion) – Microbial Contamination (2013)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML
Brand
Fusion Pharmaceuticals, LLC
Lot Codes / Batch Numbers
Lots: PL520, PL521, PL522 and PL523
Products Sold
Lots: PL520, PL521, PL522 and PL523
Fusion Pharmaceuticals, LLC is recalling Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML due to Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count abo. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA
Page updated: Jan 7, 2026