Class III · Low risk
Mefenamic Acid
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
Mefenamic Acid Capsules
Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
Class II · Moderate risk
Caffeine Powder
Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use.
Class II · Moderate risk
Zenatane (isotretinoin)
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk
Zenatane (isotretinoin)
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk
Zenatane (isotretinoin)
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk
Zenatane (isotretinoin)
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class I · High risk
Biotech Underground Tri-Ton Hardcore Formula capsules
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine.
Class III · Low risk
Fludeoxyglucose F 18 Injection
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Class II · Moderate risk
Levophed norepinephrine bitartrate
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Class II · Moderate risk
Saphris 10 mg
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Class II · Moderate risk
PHENYLephrine HCL in 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
HYDROmorphone HCL in 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
morphine sulfate in 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
morphine sulfate in 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
Nystatin Topical Powder
Presence of Foreign Substance: potential presence of plastic particles.
Class III · Low risk
Nystatin Oral Suspension
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Class I · High risk
Mibelas 24 Fe
Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
Class II · Moderate risk
Ventolin HFA
Defective Delivery System: Elevated number of units with out of specification results for leak rate