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FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
Cyanocobalamin 1,000 mcg/ml + B-Complex 100 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Cyanocobalamin 10 mg Pellet, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Copper (Cupric)Sulfate 2 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Collagenase 250 units/ml, Sterile, Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Clotrimazole 2% Otic Suspension, ml, Sterile, Room Temperature, Shake Well, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Cholecalciferol 500,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Cholecalciferol 100,000 IU /ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Bupivacaine 15 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Bupivacaine 40 mg/ml +Baclofen 130 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Brompheniramine Maleate 20 mg/ml Injectable, Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Biotin10 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, the Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Baclofen 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
B-Complex Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Ascorbic Acid 500 mg/ml Injectable Vial, Sterile Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Alprostadil 50 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Alprostadil 40 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Alprostadil 20 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Alprostadil 100 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Alprostadil 10 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Acetylcysteine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Acetyl-L-Carnitine 500 mg/ml, Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Acetyl-L-Carnitine 250 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN The Compounding Pharmacy of America Class II Terminated 20150923
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540 Novartis Pharmaceuticals Corp. Class III Terminated 20150923
IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green Vials 25 mg (NDC 17478-701-25, barcode (01)00317478701255) and 6-count 10 mL Sterile Aqueous Solvent Ampules (NDC 17478-701-10, UPC 3 17478-701-10 1) per carton, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Akorn, Inc. Class III Terminated 20150923
Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05 Hospira Inc. Class II Terminated 20150923
Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48 Pharmedium Services, LLC Class II Terminated 20150916
Surgicept (Ethyl alcohol 70% w/w) WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash in 1150 mL bottles. MARKETED BY: CafeFusion, Leawood, KS 66211, MANUFACTURED FOR: HEALTHPOINT, LTD Ft. Worth, Texas 76107, MANUFACTURED BY: DPT LABORATORIES, LTD 3300 Research Plaza Brooks City-Base, Texas 78235. NDC: 0064-1080-11 Healthpoint, Ltd Class II Terminated 20150916
METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured by AustarPharma LLC, Edison, NJ 08837, USA, Packaged by GSMS Incorporated, Camarillo, CA 93012, USA, NDC: 60429-118-05. Golden State Medical Supply Inc. Class III Terminated 20150916
Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01 Mutual Pharmaceutical Company, Inc. Class III Terminated 20150916
Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01 Mutual Pharmaceutical Company, Inc. Class III Terminated 20150916
Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01 Mutual Pharmaceutical Company, Inc. Class III Terminated 20150916
Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01 Mutual Pharmaceutical Company, Inc. Class III Terminated 20150916
Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01 Mutual Pharmaceutical Company, Inc. Class III Terminated 20150916
Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01 Mutual Pharmaceutical Company, Inc. Class III Terminated 20150916
CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged in a) 25 Drop Bags (UPC: 050428 448526) and b) 36 drop bags (UPC: 050428 476581), Over the Counter. Distributed by: CVS Pharmacy, Inc., One CVS Drive Woonsocket, RI 02895. Bestco, Inc. Class III Terminated 20150916
ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05 Oasis Medical, Inc. Class III Terminated 20150916
DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperative Skin Preparation, supplied in a) 0.9 fl oz, 26 mL Single Use Applicator w/urethane sponge and 2-count Cotton-tipped swabs per pouch, packaged in 20 pouches per case (NDC 17518-0011-08, UPC (01) 0 03 17518 01108 5) and b) 0.2 fl oz, 6 mL Single Use Applicator w/urethane sponge per pouch, packaged in 50 pouches per case (NDC 17518-0011-07, UPC (01) 0 03 17518 01107 8), OTC, Made in U.S.A. by 3M Health Care, 2510 Conway Ave., St. Paul, MN 55144. 3M Company - Health Care Business Class II Terminated 20150916
Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70 Silarx Pharmaceutical, Inc. Class III Terminated 20150909
Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA South Coast Specialty Compounding, Inc. Class II Terminated 20150909
Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA South Coast Specialty Compounding, Inc. Class II Terminated 20150909
Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA South Coast Specialty Compounding, Inc. Class II Terminated 20150909
Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA South Coast Specialty Compounding, Inc. Class II Terminated 20150909
Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA South Coast Specialty Compounding, Inc. Class II Terminated 20150909