Hands Down Medicated Lotion Soap (Kutol) – Undeclared Ingredient (2012)
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
Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS Industries, Crestwood, IL, 60446
Brand
Kutol Products Co Inc
Lot Codes / Batch Numbers
Lot #: 090204012, 090303026, 090508009, 090604024, 090725030, 090829002, 091005017, 091223002, 100115022, 100316005, 100115022, 100316005, 100329004, 100607017, 100730001, 100817014, 100921018, 101020009, 101208003, 101218007, 110405009, (L)11053105, (L)11062811, (L)11081805, and (L)11091206
Products Sold
Lot #: 090204012 , 090303026 , 090508009 , 090604024 , 090725030 , 090829002, 091005017 , 091223002 , 100115022 , 100316005 , 100115022 , 100316005,100329004 , 100607017 , 100730001 , 100817014 , 100921018 , 101020009, 101208003 , 101218007 , 110405009 , (L)11053105 , (L)11062811 , (L)11081805, and (L)11091206
Kutol Products Co Inc is recalling Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS Industries due to Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Re. 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
Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15. This dye is not approved for use in food, drugs or cosmetics.
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
IL
Page updated: Jan 7, 2026