Class II · Moderate risk Ongoing
babyganics
Reason Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Clobazam Tablets
Reason Presence of Foreign Tablets/Capsules
Class II · Moderate risk Ongoing
Duloxetine DR Capsules USP 60 mg
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP 20 mg
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP 30 mg
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk Ongoing
Progesterone Injection USP
Reason Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Class I · High risk Ongoing
Prograf
Reason Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class I · High risk Ongoing
Astagraf XL
Reason Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class II · Moderate risk Ongoing
First Aid Beauty Ultra Repair Cream
Reason CGMP Deviations; product intended for quarantine was inadvertently distributed
Class I · High risk Ongoing
Adrenalin Chloride Solution
Reason Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Class III · Low risk Ongoing
Methadone Hydrochloride Tablets
Reason Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Class I · High risk Ongoing
Systane Lubricant Eye Drops
Reason Non-Sterility
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 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 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.