Class I · High risk
Acetaminophen Injection
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
Ongoing drug recalls - open right now
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
Class II · Moderate risk
Lidocaine HCL Injection
Subpotent Drug: reduced efficacy for epinephrine
Class III · Low risk
Verapamil Hydrochloride Injection
Cross contamination with other products.
Class III · Low risk
Verapamil Hydrochloride Injection
Cross contamination with other products.
Class II · Moderate risk
Decitabine for Injection 50mg per vial
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Class II · Moderate risk
Pravastatin Sodium Tablets
Failed Dissolution Specifications: results below specifications
Class II · Moderate risk
Fludrocortisone Acetate Tablets
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Class II · Moderate risk
Infla-650 Herbal Dietary Supplement
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Class III · Low risk
Sevelamer Carbonate for Oral Suspension 0.8g packets
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Class I · High risk
Potassium Chloride Extended-Release Capsules
Failed Dissolution Specifications
Class III · Low risk
Hemp Bombs CBD Pain Freeze
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk
Hemp Bombs CBD Pain Freeze
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk
Nature's Script CBD Cryotherapy Pain Relief Roll on
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk
Hemp Bombs CBD Pain Freeze
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk
Diflorasone Diacetate Ointment
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Class II · Moderate risk
buPROPion Hydrochloride Extended-release Tablets USP
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Class III · Low risk
SinuFrin Decongestant
Sub-potent Drug
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations