Browse Drug Recalls

10 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 10 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 10 FDA drug recalls.

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DateProductReasonClassFirm
Jul 30, 2020 Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab I... Discoloration and Presence of Foreign Substance Class II Ecolab Inc
May 10, 2019 QUIK-CARE Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol), packaged in 7 oz... Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material. Class III Ecolab Inc
Feb 6, 2019 Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) b... Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... Class II Ecolab Inc
Feb 6, 2019 Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles... Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... Class II Ecolab Inc
Feb 6, 2019 Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 f... Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... Class II Ecolab Inc
Feb 6, 2019 Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles... Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... Class II Ecolab Inc
Feb 6, 2019 Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, E... Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... Class II Ecolab Inc
Nov 9, 2018 Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl... Labeling: Label mix-up - the label on the product may not match the formula in the bottle. Class II Ecolab Inc
Nov 9, 2018 Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl o... Labeling: Label mix-up - the label on the product may not match the formula in the bottle. Class II Ecolab Inc
Feb 12, 2016 Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged i... Subpotent drug Class III Ecolab Inc

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.