Class II · Moderate risk
Nimodipine Capsules 30 mg
Crystallization: Presence of crystals of Nimodipine within the capsule solution.
FDA Drug Recalls
14,806 recalls, newest first
Class III · Low risk
Major Oral Peroxide
Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.
Class III · Low risk
Capex Shampoo
Subpotent; fluocinolone acetonide.
Class I · High risk
HYDROmorphone HCl Injection
Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.
Class III · Low risk
Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin
Presence of Particulate Matter; potential for charcoal particulates
Class III · Low risk
Prometh VC with Codeine Cough Syrup
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Class III · Low risk
Prometh VC Plain
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Class II · Moderate risk
Doxazosin Tablets
Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
Class II · Moderate risk
Citalopram tablets USP
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Class II · Moderate risk
Citalopram tablets USP
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Class II · Moderate risk
Citalopram tablets USP
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Class III · Low risk
Thallous Chloride Tl 201 Injection
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Class I · High risk
Trastuzumab Kit containing 1 vial Trastuzumab
Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.
Class II · Moderate risk
Levetiracetam Tablets
Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
Class III · Low risk
Oasis Age Essential
Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.
Class II · Moderate risk
Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare
Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
Class II · Moderate risk
Ventolin HFA
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Class III · Low risk
Topiramate Tablets
Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets".
Class II · Moderate risk
Levothroid
Subpotent; 9-month stability interval
Class II · Moderate risk
Thyro-Tab 0.075 mg.
Subpotent; 9-month stability interval
Class II · Moderate risk
Levothroid
Subpotent; 9-month stability interval
Class II · Moderate risk
Thyro-Tab 0.050 mg.
Subpotent; 9-month stability interval
Class II · Moderate risk
OFIRMEV (acetaminophen)
Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.
Class II · Moderate risk
Mercaptopurine Tablets
Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.