Class II · Moderate risk Terminated
Phenoxybenzamine Hydrochloride Capsules
Reason Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
FDA Drug Recalls
17,898 recalls, newest first
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 Terminated
Budesonide Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride
Reason Subpotent Drug
Class II · Moderate risk Terminated
Rifampin Capsules USP
Reason Failed Impurities/Degradation Specification.
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 Terminated
Fosaprepitant for Injection 150 mg per vial
Reason Lack of Sterility Assurance: Aseptic process simulation failure.
Class II · Moderate risk Ongoing
Budesonide Extended-Release Tablets 9mg
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Rifampin Capsules USP 300mg
Reason Subpotent Drug and Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Rifampin Capsules USP 150mg
Reason Subpotent Drug and Failed Impurities/Degradation Specifications
Class I · High risk Terminated
Zenzedi
Reason Labeling: Label Mix-up
Class II · Moderate risk Terminated
Fluocinolone Acetonide Oil
Reason Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Class II · Moderate risk Terminated
Cefixime for Oral Suspension 100mg/5mL
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Completed
Tizanidine Tablets
Reason Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Class II · Moderate risk Terminated
Methoxsalen Capsules
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.