Class II · Moderate risk Ongoing
Infla-650 Herbal Dietary Supplement
Reason Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Ongoing
Sevelamer Carbonate for Oral Suspension 0.8g packets
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Class II · Moderate risk Terminated
Potassium Chloride Micro 10mEq K
Reason CGMP Deviations: Out of specification for dissolution
Class II · Moderate risk Terminated
Blemfree All Day Lotion
Reason CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Class II · Moderate risk Completed
Budesonide
Reason CGMP Deviations and Presence of Particulate Matter: Glass
Class I · High risk Ongoing
Potassium Chloride Extended-Release Capsules
Reason Failed Dissolution Specifications
Class III · Low risk Ongoing
Hemp Bombs CBD Pain Freeze
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk Ongoing
Hemp Bombs CBD Pain Freeze
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk Ongoing
Nature's Script CBD Cryotherapy Pain Relief Roll on
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk Ongoing
Hemp Bombs CBD Pain Freeze
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk Ongoing
Diflorasone Diacetate Ointment
Reason Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Class II · Moderate risk Ongoing
buPROPion Hydrochloride Extended-release Tablets USP
Reason Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Class III · Low risk Ongoing
SinuFrin Decongestant
Reason Sub-potent Drug
Class I · High risk Terminated
Acetaminophen Extra Strength Tablets
Reason Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
Class II · Moderate risk Terminated
Venlafaxine Hydrochloride Extended-Release Capsules
Reason Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW…
Reason This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Class II · Moderate risk Terminated
Venlafaxine Hydrochloride
Reason Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.