BD ChloraPrep FREPP Clear
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Yes — there is an active recall. 119 ongoing FDA recalls mention Alcohol (464 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Alcohol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Non-Sterility: Due to presence of Aspergillus penicillioides.
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Microbial contamination of sterile products
Lack of assurance of Sterility: potential product contamination
Lack of assurance of Sterility: potential product contamination
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Lack of Assurance of Sterility
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
CGMP Deviations
CGMP Deviations
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Lack of Assurance of Sterlity
Subpotent Drug
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Cross Contamination with Other Products.
Cross Contamination with Other Products.
cGMP Deviations
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
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