Class I - Dangerous
Labeling: Missing Label
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
Wells Pharma of Houston
Class I - Dangerous
cGMP deviations.
Class I - Dangerous
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Harrow Eye
Class I - Dangerous
Lack of Assurance of Sterility
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
B BRAUN MEDICAL
Class I - Dangerous
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class I - Dangerous
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.
Premier Dental Products
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
B BRAUN MEDICAL
Class I - Dangerous
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
B BRAUN MEDICAL
Class I - Dangerous
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class I - Dangerous
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class I - Dangerous
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
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, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-30, UPC: 383173000047.
Xiamen Kang Zhongyuan Biotechnology Co.
Class I - Dangerous
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 I - Dangerous
Chemical contamination: Presence of benzene
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-125-25, UPC: 383173000085
Xiamen Kang Zhongyuan Biotechnology Co.
Class I - Dangerous
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.
Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio 44256, Made in China, NDC: 83698-102-30, UPC: 093351037085.
Xiamen Kang Zhongyuan Biotechnology Co.
Class I - Dangerous
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.
exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC., 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC 83698-580-30, UPC: 614299398870.
Xiamen Kang Zhongyuan Biotechnology Co.
Class I - Dangerous
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 Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Class I - Dangerous
Subpotent Drug
Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR
PAYLESS COMPOUNDERS
Class I - Dangerous
Lack of Assurance of Sterility