FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated Jul 9, 2014

Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004

Reason cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert…

Gyma Laboratories Of Amer,Inc D-0022-2015

Class II · Moderate risk Terminated Jul 9, 2014

Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084

Reason cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert…

Gyma Laboratories Of Amer,Inc D-0021-2015

Class II · Moderate risk Terminated Jul 3, 2014

Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc…

Reason Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol

Mylan Pharmaceuticals Inc. NDC 0378-4596-77 D-0009-2015

Class II · Moderate risk Terminated Jun 27, 2014

fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use…

Reason Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

Healix Infusion Therapy, Inc. NDC 75901-8015-04 D-1555-2014

Class II · Moderate risk Terminated Jun 27, 2014

fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, For Institutional or Office Use Only--Not for Resale…

Reason Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

Healix Infusion Therapy, Inc. NDC 75901-8008-33 D-1554-2014

Class II · Moderate risk Terminated Jun 27, 2014

fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For…

Reason Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

Healix Infusion Therapy, Inc. NDC 75901-8007-02 D-1553-2014

Class II · Moderate risk Terminated Jun 27, 2014

fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG For Institutional or Office Use…

Reason Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

Healix Infusion Therapy, Inc. NDC 75901-8002-04 D-1552-2014

Class II · Moderate risk Terminated Jun 27, 2014

fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale…

Reason Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

Healix Infusion Therapy, Inc. NDC 75901-8008-90 D-1551-2014

Class II · Moderate risk Terminated Jun 27, 2014

Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira…

Reason Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.

Hospira Inc. D-1433-201

Class II · Moderate risk Terminated Jun 26, 2014

Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC…

Reason CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not…

Caraco Pharmaceutical Laboratories, Ltd. NDC 62756-294-88 D-1511-2014

Class II · Moderate risk Terminated Jun 26, 2014

Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC…

Reason CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not…

Caraco Pharmaceutical Laboratories, Ltd. NDC 62756-293-88 D-1510-2014