Dots Scented Antibacterial Hand Gel Orange
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
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.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May 2018 however the correct expiration date is May 2019. In addition, device component (syringe) lacks 510(k) clearance.
CGMP Deviations: Product was released to market prior to microbiological testing.
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Microbial contamination
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
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