Class III · Low risk Ongoing
Glimepiride Tablets
Reason Misprint on tablet
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Fosfomycin Tromethamine Granules for Oral Solution
Reason Failed Impurities/Degradation Specification: Out of specification for organic impurities
Class II · Moderate risk Ongoing
Hydrogen Peroxide Oral Rinse
Reason CGMP Deviations: products may not conform to the labeled specifications.
Class II · Moderate risk Ongoing
OralProCare medicated lip treatment
Reason CGMP Deviations: products may not conform to the labeled specifications.
Class I · High risk Ongoing
Neptune's Fix
Reason Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I · High risk Ongoing
Neptune's Fix
Reason Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I · High risk Ongoing
Neptune's Fix
Reason Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class II · Moderate risk Ongoing
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Vasostrict
Reason Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Class II · Moderate risk Ongoing
Medline Remedy Clinical TREAT Antifungal Cream
Reason Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Class II · Moderate risk Ongoing
Budesonide Extended-Release Tablets 9mg
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Ibuprofen and Famotidine Tablets 800mg/26.6mg
Reason Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Class II · Moderate risk Ongoing
buPROPion Hydrochloride Extended-Release Tablets
Reason Presence of Foreign Tablets/Capsules
Class I · High risk Ongoing
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk Ongoing
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk Ongoing
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk Ongoing
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk Ongoing
FentaNYL citrate PF
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk Ongoing
FentaNYL citrate PF
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class II · Moderate risk Ongoing
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose
Reason Lack of Sterility Assurance
Class II · Moderate risk Ongoing
Quality Choice No Drip Severe Congestion Nasal Pump Mist
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II · Moderate risk Ongoing
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist…
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II · Moderate risk Ongoing
Premier Value Tussin Cough DM
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II · Moderate risk Ongoing
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class I · High risk Ongoing
Robitussin Honey CF Max Nighttime Adult
Reason Microbial Contamination of Non-Sterile Products