Class II · Moderate risk
CVS Pharmacy Fiber Capsules for Regularity
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
FDA Drug Recalls
530 recalls, newest first
Class II · Moderate risk
Best Choice Health Care
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter; product may contain fibrous material
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
Class I · High risk
BiCNU (Carmustine for injection)
Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of an overfilled vial discovered during stability testing for a single carmustine lot.
Class II · Moderate risk
Diazepam Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
Preservative-Free MORPHINE Sulfate Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Class II · Moderate risk
Atrovent HFA Inhalation Aerosol
Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol
Class II · Moderate risk
I-C Drops
Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use.
Class I · High risk
Reumofan Plus Tablets
Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug.
Class I · High risk
Mojo Nights for Her
Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.
Class I · High risk
Mojo Nights
Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.
Class III · Low risk
Novarel¿ (Chorionic Gonadotropin for injection, USP)
Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products.
Class III · Low risk
Venlafaxine ER 150mg
Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."
Class II · Moderate risk
Atorvastatin Calcium Tablets
Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
Class II · Moderate risk
Nimodipine Capsules 30 mg
Crystallization: Presence of crystals of Nimodipine within the capsule solution.
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.