Class II · Moderate risk Ongoing
Phenylephrine Hydrochloride Injectable Solution
Reason cGMP deviations.
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Blemish Spot Treatment
Reason Failed Stability Specifications
Class II · Moderate risk Ongoing
EPINEPHRINE Injection
Reason Lack of Assurance of Sterility
Class III · Low risk Ongoing
Magnesium Chloride
Reason Subpotent drug
Class II · Moderate risk Ongoing
Prazosin Hydrochloride Capsules
Reason cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Class II · Moderate risk Ongoing
Prazosin Hydrochloride Capsules
Reason cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Class II · Moderate risk Ongoing
Prazosin Hydrochloride Capsules
Reason cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Class II · Moderate risk Ongoing
Pantoprazole Sodium
Reason Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Class II · Moderate risk Ongoing
Fluocinonide
Reason Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class II · Moderate risk Ongoing
Fluocinonide
Reason Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class II · Moderate risk Ongoing
Fluocinonide
Reason Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class II · Moderate risk Ongoing
Artificial Tears Lubricant Eye Drops
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Memantine Hydrochloride Extended-Release
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
GE Healthcare Omnipaque
Reason Presence of particulate matter
Class II · Moderate risk Ongoing
GE Healthcare Omnipaque
Reason Presence of particulate matter
Class I · High risk Ongoing
Kian Pee Wan Capsules
Reason Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
Class II · Moderate risk Ongoing
Furosemide Tablets
Reason CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Class II · Moderate risk Ongoing
QC Quality Choice
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk Ongoing
QC Quality Choice
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk Ongoing
QC Quality Choice
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk Ongoing
QC Quality Choice
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk Ongoing
QC Quality Choice
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk Ongoing
QC Quality Choice
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk Ongoing
QC Quality Choice
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk Ongoing
MGC Health
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.