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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.