Class III · Low risk
Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg
Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
CHIROTHIN Dietary Supplement
Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.
Class III · Low risk
Nicotine Polacrilex Lozenge
Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Class II · Moderate risk
Propranolol Hydrochloride Injection
CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.
Class II · Moderate risk
Metoclopramide Oral Solution
Defective Container: Product leaks when inverted.
Class I · High risk
CUBICIN (daptomycin for injection)
Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
Class II · Moderate risk
Rector's Remedy OINTMENT
Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing and lack of OTC drug labeling requirements.
Class II · Moderate risk
Whitfield's OINTMENT B.P.
Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.
Class II · Moderate risk
Whitfield Lotion
Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
Class II · Moderate risk
Ferrol EXPECTORANT
Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
Class II · Moderate risk
Mustarcreme
Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
Class II · Moderate risk
alcosulph Astringent Lotion
Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
Class II · Moderate risk
alcosulph Moisturizing Cream
Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
Class I · High risk
Dianeal Low Calcium
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Class II · Moderate risk
Alcohol-Free Hand Sanitizer
Microbial Contamination of Non-Sterile Product
Class II · Moderate risk
Children's Q-Pap
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
Class II · Moderate risk
Children's Q-Pap
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
Class II · Moderate risk
Children's Q-Pap
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
Class III · Low risk
Rifampin for Injection USP
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
Class II · Moderate risk
ZyGenerics ATENOLOL Tablets
Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
Class II · Moderate risk
ProSol - sulfite-free
Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).
Class I · High risk
CUBICIN (daptomycin for injection)
Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.
Class II · Moderate risk
CYTARAbine for Injection USP
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; complaints of mold in the overpouch