Class III · Low risk Ongoing
Pitavastatin Tablets
Reason Failed Impurities/Degradation Specifications.
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Ongoing
Famciclovir Tablets
Reason Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Class II · Moderate risk Ongoing
Kimmtrak
Reason Subpotent Drug
Class I · High risk Ongoing
Orajel Baby
Reason Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Class I · High risk Ongoing
Zicam Nasal Allclear
Reason Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Class I · High risk Ongoing
Zicam Cold Remedy Medicated Nasal Swabs
Reason Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Class II · Moderate risk Ongoing
LIDOcaine HCL Sterile Injection
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk Ongoing
LIDOcaine HCL Sterile Injection
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk Ongoing
KETAmine Hydrochloride Injection
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk Ongoing
KETAmine Hydrochloride Injection
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk Ongoing
BUPIVAcaine HCL Sterile injection
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk Ongoing
LIDOcaine HCl Injection
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class I · High risk Ongoing
Sulfamethoxazole and Trimethoprim Tablets
Reason Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Class II · Moderate risk Ongoing
Testo-200
Reason Marketed Without an Approved NDA/ANDA
Class II · Moderate risk Ongoing
Icosapent Ethyl Capsules 1 gram
Reason Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Class II · Moderate risk Ongoing
Gentamicin Injection
Reason Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Class III · Low risk Ongoing
Levothyroxine Sodium Tablets
Reason Presence of a foreign substance: black hair found embedded in tablet.
Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Azelastine HCl Ophthalmic Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ketorolac Tromethamine Ophthalmic Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
DOBUTamine Injection
Reason Discoloration; discolored solution from cracked vials
Class II · Moderate risk Ongoing
Lacosamide Oral Solution
Reason Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Fluoxetine Tablets
Reason CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II · Moderate risk Completed
Fluoxetine Tablets
Reason CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.