Class II · Moderate risk
IMC Wash-Free Hand Sanitizer
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
FDA Drug Recalls
43 recalls, newest first
Class II · Moderate risk
IMC Wash-Free Hand Sanitizer
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk
IMC Wash-Free Hand Sanitizer
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class I · High risk
TraZODONE Hydrochloride Tablets USP 100 mg
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Class II · Moderate risk
Sildenafil Tablets USP 100 mg
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Class II · Moderate risk
bio aaa Alcohol en Gel Antibacterial
CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.
Class I · High risk
Red-E Tablet
Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.
Class I · High risk
Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing…
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk
Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk
SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk
SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class II · Moderate risk
Florance Morris ANTISEPTIC Hand Sanitizer
CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class I · High risk
Florance Morris ANTISEPTIC Hand Sanitizer
Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
Class I · High risk
Incredible Products Gelbac T Antibacterial Hand Gel
Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
Class II · Moderate risk
Command Brands GelAnti Bac Instant Hand Sanitizer
CGMP Deviation: Potential contamination with undeclared methanol.
Class I · High risk
Herbacil
Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained methanol.
Class II · Moderate risk
Herbacil
CGMP Deviations: products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class I · High risk
Born Basic.
Chemical Contamination: Born Basic Anti Bac 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.
Class II · Moderate risk
LUX EOI Hand Sanitizing Gel
CGMP Deviations: Born Basic Anti Bac 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.
Class II · Moderate risk
Born Basic.
CGMP Deviations: Born Basic Anti Bac 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.
Class II · Moderate risk
scent theory KEEP CLEAN Moisturizing Hand Sanitizer
CGMP Deviations: Born Basic Anti Bac 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.
Class II · Moderate risk
scent theory KEEP IT CLEAN
CGMP Deviations: Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class I · High risk
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class I · High risk
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class I · High risk
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content