Class II · Moderate risk
Theraflu Sugar-Free Nighttime Severe Cold & Cough
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
FDA Drug Recalls
1,969 recalls, newest first
Class II · Moderate risk
Theraflu MAX-D Severe Cold & Flu
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu Multi-Symptom Severe Cold
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu Severe Cold & Cough powder packets containing Daytime formula
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu Daytime Severe Cold & Cough
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu Flu & Sore Throat
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class I · High risk
Enteric Coated Aspirin
Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets.
Class II · Moderate risk
Belladonna Alkaloids/PB
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.
Class III · Low risk
Prednisone Tablet USP
Labeling: Missing Label; missing label on blister card
Class III · Low risk
Medroxyprogesterone acetate
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Class II · Moderate risk
ChloraPrep With Tint
Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
Class I · High risk
Bethel 30 capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
VECURONIUM Bromide for Injection
CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.
Class II · Moderate risk
Parsel Plus
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
No Doz
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
Excedrin Migraine
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
Excedrin Extra Strength
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
Class II · Moderate risk
VersaPharm Incorporated
Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.