Class I · High risk
Fruta BIO 400 mg capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein .
FDA Drug Recalls
18,003 recalls, newest first
Class I · High risk
JIANFEIJINDAN Activity Girl Capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine
Class I · High risk
REDUCE WEIGHT FRUTA PLANTA Capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein.
Class II · Moderate risk
Teva Hydroxyzine Pamoate Capsules
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Class II · Moderate risk
Teva Dextroamphetamine Saccharate
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.
Class II · Moderate risk
Teva Hydroxyzine Pamoate Capsules
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Class II · Moderate risk
Teva Ethambutol Hydrochloride Tablets
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
Class II · Moderate risk
Heparin Sodium Injection
Subpotent; 18 month time point
Class II · Moderate risk
Atorvastatin Calcium Tablets
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
ROHTO Redness Relief
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Class II · Moderate risk
ROHTO Cooling Eye Drops
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Class II · Moderate risk
ROHTO Dry Eye
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Class II · Moderate risk
ROHTO Redness Relief
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Class II · Moderate risk
ROHTO Redness Relief
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets USP
Failed Tablet/Capsule Specifications; Product contains broken tablets.
Class II · Moderate risk
Guaifenesin USP
Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.
Class I · High risk
PRO ArthMax Dietary Supplement tablets
Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin
Class III · Low risk
Liptruzet (ezetimibe and atorvastin)
Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Class III · Low risk
Liptruzet (ezetimibe and atorvastin)
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Class III · Low risk
Liptruzet (ezetimibe and atorvastin)
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Class III · Low risk
Liptruzet (ezetimibe and atorvastin)
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Class I · High risk
DOBUTamine Injection
Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
Class II · Moderate risk
Therametics Complexion Repair Topical Rehydrating Emulsion in 50…
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk
Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50…
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.