Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

390 recalls · Class II, newest first

Class II · Moderate risk

Assured Instant Hand Sanitizer Vitamin E and Aloe

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Ongoing Microbial contamination Albek De Mexico S.A. De C.V. D-0081-2021
Class II · Moderate risk

Assured Instant Hand Sanitizer Aloe & Moisturizers

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Ongoing Microbial contamination Albek De Mexico S.A. De C.V. D-0080-2021
Class II · Moderate risk

Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Ongoing Microbial contamination Albek De Mexico S.A. De C.V. D-0079-2021
Class II · Moderate risk

NuuxSan Instant ANTIBACTERIAL HAND SANITIZER

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Ongoing Microbial contamination Albek De Mexico S.A. De C.V. D-0078-2021
Class II · Moderate risk

RELPAX (eletriptan HBr)

Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.

Terminated Microbial contamination Pfizer Inc. NDC 0049-2340-45 D-1845-2019
Class II · Moderate risk

PRE-TAT (lidocaine)

Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.

Terminated Microbial contamination Ridge Properties, LLC NDC 69804-019-14 D-1857-2019
Class II · Moderate risk

PRE-TAT (lidocaine)

Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.

Terminated Microbial contamination Ridge Properties, LLC NDC 69804-002-05 D-1856-2019
Class II · Moderate risk

MONSEL'S (Ferric Subsulfate)

Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.

Terminated Microbial contamination Dercher Enterprises, Inc., DBA Gordon Laboratories NDC 10481-0112-8 D-1528-2019
Class II · Moderate risk

Clobazam Oral Suspension

Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.

Terminated Microbial contamination Bionpharma Inc. NDC 69452-116-45 D-1519-2019
Class II · Moderate risk

Kool Comfort Cooling Pain Relief

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

Terminated Microbial contamination US Pharmaceuticals Inc. D-1739-2019
Class II · Moderate risk

Cool Hot Ice Analgesic Gel

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

Terminated Microbial contamination US Pharmaceuticals Inc. D-1738-2019

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