Class I · High risk Ongoing
Systane Lubricant Eye Drops
Reason Non-Sterility
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Colchicine Capsules 0.6 mg
Reason Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Class II · Moderate risk Ongoing
medroxyPROGESTERone Acetate Injectable Suspension
Reason CGMP Deviations
Class III · Low risk Ongoing
Polyvinyl Alcohol Ophthalmic Solution 1.4%
Reason LABELING: LABEL MIX-UP
Class III · Low risk Ongoing
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%…
Reason LABELING: LABEL MIX-UP
Class II · Moderate risk Terminated
glipiZIDE
Reason Failed Dissolution Specifications:
Class I · High risk Ongoing
FOUZEE SugarLin HERBAL FORMULA capsules
Reason Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Class II · Moderate risk Ongoing
Ciprofloxacin Ophthalmic Solution USP
Reason Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class III · Low risk Terminated
Atropine Sulfate Ophthalmic Solution
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Clobazam Tablets
Reason Presence of Foreign Tablets/Capsules
Class III · Low risk Ongoing
Diphenhydramine HCl 50 mg
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk Ongoing
Diphenhydramine HCl 25 mg
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk Ongoing
Diphenhydramine HCl 25 mg
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk Ongoing
Acetaminophen Extra Strength 500 mg
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk Ongoing
Acetaminophen
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk Ongoing
Acetaminophen Regular Strength
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk Ongoing
Acetaminophen Extra Strength 500 mg
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class I · High risk Ongoing
Nhan Sam Tuyet Lien Truy Phong Hoan
Reason Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
Class I · High risk Ongoing
FORCE FOREVER 400mg Tablets
Reason Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Class II · Moderate risk Ongoing
Dabigatran Etexilate
Reason CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class II · Moderate risk Ongoing
Dabigatran Etexilate
Reason CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II · Moderate risk Ongoing
Dapsone Gel 7.5%
Reason Crystallization
Class II · Moderate risk Ongoing
Dapsone Gel 7.5%
Reason Crystallization