Class II · Moderate risk
Eyebright Concentrate Topical Eye Rinse
Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products
FDA Drug Recalls
14,806 recalls, newest first
Class I · High risk
Magnesium Sulfate Injection
Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
Class II · Moderate risk
INK-EEZE Tattoo Black Label Numbing Spray
Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.
Class II · Moderate risk
INK-EEZE Tattoo Numbing Spray
Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.
Class II · Moderate risk
Zolpidem Tartrate Tablets 5 mg
Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.
Class III · Low risk
Folic Acid Injection
Failed Impurities/Degradation Specification
Class II · Moderate risk
Nimodipine Capsules 30 mg
Crystallization; crystallized nimodipine
Class II · Moderate risk
Metronidazole Injection USP
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Class II · Moderate risk
Sodium Chloride Injection
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Class II · Moderate risk
Lidocaine Hydrochloride and 5% Dextrose Injection
Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Class II · Moderate risk
Heparin Sodium and 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Class II · Moderate risk
5% Dextrose Injection
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Class II · Moderate risk
Ondansetron Injection
Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
Class I · High risk
Methotrexate Injection
Presence of Particulate Matter: Found during examination of retention samples.
Class I · High risk
Xiyouji Qingzhi Capsule
Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Class I · High risk
JaDera
Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Class II · Moderate risk
Enablex (darifenacin)
Failed Impurities/Degradation Specifications: unspecified degradation product
Class II · Moderate risk
West-ward Belladonna Alkaloids with Phenobarbital Tablets
Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.
Class II · Moderate risk
West-ward Belladonna Alkaloids with Phenobarbital Tablets
Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.
Class II · Moderate risk
Diazepam Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
Ranitidine Syrup
Failed Impurity/Degradation Specification; "Related Compound C"
Class III · Low risk
Excedrin
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Class III · Low risk
Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.