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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
All Germall (diazolidinyl urea and iodopropynyl butylcarbamate) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. Reliable Rexall-A Compounding Pharmacy Class II Terminated 20160713
All betamethasone diproprionate Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. Reliable Rexall-A Compounding Pharmacy Class II Terminated 20160713
All monobenzone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. Reliable Rexall-A Compounding Pharmacy Class II Terminated 20160713
All carbomer Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. Reliable Rexall-A Compounding Pharmacy Class II Terminated 20160713
All progesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. Reliable Rexall-A Compounding Pharmacy Class II Terminated 20160713
All Peterson Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. Reliable Rexall-A Compounding Pharmacy Class II Terminated 20160713
All TRIE Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. Reliable Rexall-A Compounding Pharmacy Class II Terminated 20160713
All estriol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. Reliable Rexall-A Compounding Pharmacy Class II Terminated 20160713
All testosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. Reliable Rexall-A Compounding Pharmacy Class II Terminated 20160713
CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. Reliable Rexall-A Compounding Pharmacy Class I Terminated 20160713
All 4-aminopyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. Reliable Rexall-A Compounding Pharmacy Class II Terminated 20160713
PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only, Healix Infusion Therapy Inc, 1075 W Park One Drive, Suite 200, Sugar Land Texas 77478, Product Code: 75901-1205-35. QuVa Pharma, Inc. Class I Terminated 20160713
Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvine, CA 92612. UPC 300238335159 Allergan Sales, LLC Class II Terminated 20160713
Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023-8335-10) tubes, Allergan Inc, Irvine, CA 92612 Allergan Sales, LLC Class II Terminated 20160713
Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01 Dr. Reddy's Laboratories, Inc. Class III Terminated 20160713
Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant screw closure, Rx only, Distributed by: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Manufactured by: Lyne Laboratories, Inc., Brockton, MA 02301, NDC 64980-0504-48 Lyne Laboratories, Inc. Class III Terminated 20160713
Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01 Aidarex Pharmaceuticals LLC Class III Terminated 20160706
Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10 Actavis Pharma Inc Class III Terminated 20160706
SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ 08807. NDC: 0187-4220-10. Valeant Pharmaceuticals North America LLC Class III Terminated 20160706
CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523 Dr. Reddy's Laboratories, Inc. Class III Terminated 20160706
Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03 KVK-Tech, Inc. Class III Terminated 20160706
Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS Vital Care Compounder Class II Terminated 20160706
Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS Vital Care Compounder Class II Terminated 20160706
Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS Vital Care Compounder Class II Terminated 20160706
aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA Liniment Topical Analgesic 8 fl oz. bottle, Manufactured by Coats International, Inc., the ALOE SOURCE SPORT Sport Thermogenic Eucalyptus Cream 1 fl oz. plastic bottle, Dallas, TX 75243, NDC 58826-704-08, UPC 732295704089 The Aloe Source Class II Terminated 20160706
Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30 Lupin Pharmaceuticals Inc. Class III Terminated 20160706
Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ 08512, NDC 43547-331-09. Prinston Pharmaceutical Inc Class III Terminated 20160629
VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30 Virtus Pharmaceuticals, Llc Class III Terminated 20160629
Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada Attix Pharmaceuticals Inc Class III Terminated 20160629
Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01 Sandoz, Inc Class III Terminated 20160629
Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01 Sandoz, Inc Class III Terminated 20160629
Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10 Virtus Pharmaceuticals, Llc Class III Terminated 20160629
1% Clotrimazol cream, 30 mg tube, UPC 501318644335 Profarma Distributors LLC Class II Terminated 20160629
VERMOX Tablets 500 mg, 1-count box, UPC 501109900596 Profarma Distributors LLC Class II Terminated 20160629
VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619 Profarma Distributors LLC Class II Terminated 20160629
tabcin NOCHE; Capsules,12-count box, UPC 501008485033 Profarma Distributors LLC Class II Terminated 20160629
tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057 Profarma Distributors LLC Class II Terminated 20160629
Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11 Par Pharmaceutical Class III Terminated 20160622
Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37 Fresenius Kabi USA, LLC Class II Terminated 20160622
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01 Sandoz Inc Class III Terminated 20160622
Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 68682-409-10. Valeant Pharmaceuticals North America LLC Class III Terminated 20160622
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 0187-4100-10. Valeant Pharmaceuticals North America LLC Class III Terminated 20160622
Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01 Hospira Inc. Class II Terminated 20160622
Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC 0 00950 86006 8. Valeant Pharmaceuticals North America LLC Class III Terminated 20160622
Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30. Galderma Laboratories, L.P. Class III Terminated 20160622
Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32 Nostrum Laboratories, Inc. Class II Terminated 20160622
Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1 Genzyme Corporation / Genzyme Biosurgery Class III Terminated 20160622
ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 Well Care Compounding Pharmacy Class II Terminated 20160615
ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 Well Care Compounding Pharmacy Class II Terminated 20160615
CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 Well Care Compounding Pharmacy Class II Terminated 20160615