US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

Class II · Moderate risk Terminated

Arginine Injections 100 mcg/mL

Reason Lack of Assurance of Sterility

Pharm D Solutions, LLC NDC 69699-1414-20 D-0137-2019
Class II · Moderate risk Terminated

Acetylcysteine Injection 10 mg/5 mL

Reason Lack of Assurance of Sterility

Pharm D Solutions, LLC NDC 69699-1424-10 D-0136-2019
Class II · Moderate risk Terminated

Actoplus met XR

Reason Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.

Takeda Development Center Americas, Inc. D-0026-2019
Class II · Moderate risk Terminated

Minivelle

Reason Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

Noven Pharmaceuticals, Inc. NDC 68968-6675-8 D-1210-2018
Class II · Moderate risk Terminated

Minivelle

Reason Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

Noven Pharmaceuticals, Inc. NDC 68968-6625-8 D-1209-2018
Class II · Moderate risk Terminated

Minivelle

Reason Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

Noven Pharmaceuticals, Inc. NDC 68968-6650-8 D-1208-2018
Class II · Moderate risk Terminated

Minivelle

Reason Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

Noven Pharmaceuticals, Inc. NDC 68968-6610-8 D-1207-2018
Class II · Moderate risk Terminated

Synjardy

Reason Cross Contamination With Other Products:

Boehringer Ingelheim Pharmaceuticals, Inc. NDC 0597-0175-18 D-1217-2018
Class II · Moderate risk Terminated

Tizanidine HCl Tablets

Reason Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .

Dr. Reddy's Laboratories, Inc. NDC 55111-179-15 D-1191-2018
Class II · Moderate risk Terminated

Arthritis Pain Relief Homeopathic Formula

Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

Beaumont Bio-med, Inc. NDC 58066-7042-7 D-1199-2018
Class II · Moderate risk Terminated

Colds & Flu Response Homeopathic Formula

Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

Beaumont Bio-med, Inc. NDC 58066-7012-7 D-1198-2018
Class II · Moderate risk Terminated

Allergy & Hay Fever Relief Homeopathic Formula

Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

Beaumont Bio-med, Inc. NDC 58066-7011-7 D-1197-2018
Class II · Moderate risk Terminated

Muscle & Joint Pain Relief Homeopathic Formula

Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

Beaumont Bio-med, Inc. NDC 58066-7041-7 D-1196-2018
Class II · Moderate risk Terminated

Diarrhea Response Homeopathic Formula

Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

Beaumont Bio-med, Inc. NDC 58066-7022-7 D-1195-2018
Class II · Moderate risk Terminated

Sore Throat & Laryngitis Response Homeopathic Formula

Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

Beaumont Bio-med, Inc. NDC 58066-7014-7 D-1194-2018
Class II · Moderate risk Terminated

Sinus Response Homeopathic Formula

Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

Beaumont Bio-med, Inc. NDC 58066-7013-7 D-1193-2018
Class II · Moderate risk Terminated

Skin Irritation & Itch Response Homeopathic Formula

Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

Beaumont Bio-med, Inc. NDC 58066-7002-7 D-1192-2018
Class II · Moderate risk Terminated

NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel

Reason CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.

BioLyte Laboratories, LLC NDC 58368-002-02 D-0002-2019
Class II · Moderate risk Terminated

Thyroid powder

Reason CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

Alkano Chemicals, Inc NDC 7807-0170-11 D-0008-2019
Class II · Moderate risk Terminated

Thyroid

Reason CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

Humco Holding Group, Inc NDC 0395-6580-43 D-0024-2019
Class II · Moderate risk Terminated

Thyroid

Reason CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

Humco Holding Group, Inc NDC 0395-8077-62 D-0023-2019
Class II · Moderate risk Terminated

Thyroid

Reason CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

Humco Holding Group, Inc NDC 0395-8077-43 D-0022-2019
Class II · Moderate risk Terminated

Ethosuximide Capsules

Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.

Akorn, Inc. D-1183-2018