Class II · Moderate risk Terminated
Losartan Potassium and Hydrochlorothiazide Tablets USP
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Losartan Potassium and Hydrochlorothiazide Tablets USP
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium and Hydrochlorothiazide Tablets USP
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Janumet
Reason Presence of foreign substance: Presence of stainless steel particulates in tablets.
Class II · Moderate risk Ongoing
Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class I · High risk Ongoing
Suave 24-Hour Protection Aerosol Antiperspirant Powder scent
Reason Chemical contamination: presence of benzene
Class I · High risk Terminated
The Mandalorian Hand Sanitizer
Reason Chemical Contamination; FDA analysis found product to contain benzene
Class I · High risk Terminated
Mickey Mouse Hand Sanitizer
Reason Chemical Contamination; FDA analysis found product to contain methanol
Class III · Low risk Terminated
Wal-Tussin DM
Reason Incorrect/Undeclared Excipient: Product contains alcohol
Class I · High risk Terminated
Pink Pussycat SENSUAL ENHANCEMENT capsule
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Terminated
IDArubicin Hydrochloride Injection USP 5gm/5mL
Reason Presence of Particulate Matter: Product was found to contain silica and iron oxide
Class II · Moderate risk Terminated
Preferred Pharmaceuticals
Reason Out of specification results observed in dissolution during long term stability testing.
Class II · Moderate risk Completed
Magnesium Hydroxide 1200mg
Reason CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk Completed
Milk of Magnesia USP
Reason CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk Completed
Acetaminophen Oral Solution
Reason CGMP Deviations: Failure to properly investigate failed microbial testing.
Class I · High risk Completed
Magnesium Hydroxide 1200mg
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Completed
Milk of Magnesia USP
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Diclofenac Sodium Topical Solution 1.5% w/w
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Class II · Moderate risk Terminated
Econazole Nitrate Cream
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk Terminated
Clobetasol Propionate Lotion 0.05%
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Capsules
Reason Failed Dissolution Specifications; during long term stability testing.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Capsules
Reason Failed Dissolution Specifications; during long term stability testing.