Browse Drug Recalls

14 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 14 FDA drug recalls.

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DateProductReasonClassFirm
Apr 22, 2019 AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium ch... CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... Class II Inopak Ltd
Apr 22, 2019 ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Fo... CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... Class II Inopak Ltd
Apr 22, 2019 Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a... CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... Class II Inopak Ltd
Apr 22, 2019 Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel... CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... Class II Inopak Ltd
Apr 22, 2019 Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE San... CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... Class II Inopak Ltd
Apr 22, 2019 INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) ... CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... Class II Inopak Ltd
Apr 22, 2019 INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 05857... CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... Class II Inopak Ltd
Apr 22, 2019 Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soa... CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... Class II Inopak Ltd
Apr 22, 2019 Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with T... CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... Class II Inopak Ltd
Apr 22, 2019 Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 m... CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... Class II Inopak Ltd
May 16, 2018 Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches... Microbial contamination of NonSterile Product; FDA analysis returned out of specification results... Class II Inopak Ltd
Aug 23, 2017 Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Univer... GMP Deviations; potential bacterial contamination may have been introduced to products through a ... Class II Inopak Ltd
Aug 23, 2017 Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Dis... GMP Deviations; potential bacterial contamination may have been introduced to products through a ... Class II Inopak Ltd
Aug 23, 2017 Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18... GMP Deviations; potential bacterial contamination may have been introduced to products through a ... Class II Inopak Ltd

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.