Drugs & Medicine Recalls
Pharmaceutical recall notices, chemical impurities, and biological contamination.
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashvi...
Lack of Assurance of Sterility
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B...
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: L...
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun ...
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, ND...
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx ...
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey...
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.
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cher...
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.
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Sk...
Subpotent Drug
Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx...
Lack of Assurance of Sterility
HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 F...
Chemical contamination: Presence of benzene
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals ...
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free...
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.
caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-...
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.
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Ster...
Labelling: Illegible label
Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials,...
Lack of Assurance of Sterility
Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceuti...
Subpotent drug
exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor ...
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.
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Suga...
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.
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals ...
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar,...
Subpotent Drug
SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, S...
Chemical contamination: Presence of benzene
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufac...
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar...
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.