Class II · Moderate risk
Zonisamide Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
FDA Drug Recalls
1,356 recalls, newest first
Class II · Moderate risk
Tamsulosin Hydrochloride Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Famotodine Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Clarithromycin Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Azithromycin Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Zolpidem Tartrate Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Extended Phenytoin Sodium Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lamotrigine Extended-Release Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Amlodipine Besylate Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class I · High risk
Testosterone Cypionate 200 mg/mL in Sesame oil
Incorrect Product Formulation: Vials labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil are being recalled because they contains Estradiol Valerate 20 mg/mL.
Class III · Low risk
Bromfenac Ophthalmic Solution 0.09%
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Class II · Moderate risk
Glutathione 200 mg/mL Injectable
Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.
Class III · Low risk
Eye Drops Advanced Relief
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk
Eye Drops Industrial Strength
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk
Eye Drops A.C.
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk
Eye Drops (Tetrahydrozoline HCl 0.05%)
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk
Z-Cote Hp 1 Transparent Zinc Oxide
cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.
Class II · Moderate risk
Cephalexin Monohydrate Capsules
CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
Class II · Moderate risk
Propranolol Hydrochloride Injection
CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.
Class II · Moderate risk
Tetrahydrozoline Hydrochloride
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class II · Moderate risk
Tetrahydrozoline HCL
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class II · Moderate risk
Clonidine HCL
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.