Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Capsules USP
Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
methylcobalamin 1mg/1mL
Lack of Assurance of Sterility
Class II · Moderate risk
Option 2
Defective Container: Carton is missing the tablet blister strip and tablet.
Class I · High risk
Paliperidone Extended-Release Tablets
Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
Class III · Low risk
BuPROPion HCL Tablets
Failed Moisture Limits: Product tested out-of-specification for moisture content.
Class II · Moderate risk
Methocarbamol
CGMP Deviations: Lack of quality assurance at the API manufacturer.
Class I · High risk
CaverFlo Natural Herbal Coffee
Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk
Class I · High risk
BRILINTA (ticagrelor)
Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
Class III · Low risk
PONSTEL (Mefanamic Acid)
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Class III · Low risk
Mefenamic Acid
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
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.