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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
Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL THE COMPOUNDING SHOP, INC. Class II Terminated 20130612
Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL THE COMPOUNDING SHOP, INC. Class II Terminated 20130612
Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL THE COMPOUNDING SHOP, INC. Class II Terminated 20130612
Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL THE COMPOUNDING SHOP, INC. Class II Terminated 20130612
Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL THE COMPOUNDING SHOP, INC. Class II Terminated 20130612
Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL THE COMPOUNDING SHOP, INC. Class II Terminated 20130612
Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL THE COMPOUNDING SHOP, INC. Class II Terminated 20130612
Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL THE COMPOUNDING SHOP, INC. Class II Terminated 20130612
Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL THE COMPOUNDING SHOP, INC. Class II Terminated 20130612
Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL THE COMPOUNDING SHOP, INC. Class II Terminated 20130612
Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL THE COMPOUNDING SHOP, INC. Class II Terminated 20130612
Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL THE COMPOUNDING SHOP, INC. Class II Terminated 20130612
Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL THE COMPOUNDING SHOP, INC. Class II Terminated 20130612
Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL THE COMPOUNDING SHOP, INC. Class II Terminated 20130612
Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3); b) 14-count tablets per bottle (NDC 54868-0158-1); c) 20-count tablets per bottle (NDC 54868-0158-5); d) 21-count tablets per bottle (NDC 54868-0158-0); e) 30-count tablets per bottle (NDC 54868-0158-8), Rx only, Mfg. By: Pliva Krakow Pharma. Comp., Krakow, Poland; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146. Physicians Total Care, Inc. Class II Terminated 20130612
ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16 TG United, Inc. Class II Terminated 20130612
ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30 TG United, Inc. Class II Terminated 20130612
Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16 TG United, Inc. Class II Terminated 20130612
Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0001-30 TG United, Inc. Class II Terminated 20130612
Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30 TG United, Inc. Class II Terminated 20130612
Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30 TG United, Inc. Class II Terminated 20130612
Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16 TG United, Inc. Class II Terminated 20130612
TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30 TG United, Inc. Class II Terminated 20130612
TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-068-16 TG United, Inc. Class II Terminated 20130612
TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16 TG United, Inc. Class II Terminated 20130612
Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16 TG United, Inc. Class II Terminated 20130612
Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0085-16 TG United, Inc. Class II Terminated 20130612
CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30 TG United, Inc. Class II Terminated 20130612
CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30 TG United, Inc. Class II Terminated 20130612
TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10 TG United, Inc. Class II Terminated 20130612
Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60 TG United, Inc. Class II Terminated 20130612
Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60 TG United, Inc. Class II Terminated 20130612
Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01 TG United, Inc. Class II Terminated 20130612
Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16 TG United, Inc. Class II Terminated 20130612
BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58605-151-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 TG United, Inc. Class II Terminated 20130612
BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01 b) 20 ml NDC 58605-150-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 TG United, Inc. Class II Terminated 20130612
BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01 TG United, Inc. Class II Terminated 20130612
BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01 TG United, Inc. Class II Terminated 20130612
Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01 TG United, Inc. Class II Terminated 20130612
Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01 TG United, Inc. Class II Terminated 20130612
Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30 TG United, Inc. Class II Terminated 20130612
Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-604-30 TG United, Inc. Class II Terminated 20130612
BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16 TG United, Inc. Class II Terminated 20130612
Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01 TG United, Inc. Class II Terminated 20130612
Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01 TG United, Inc. Class II Terminated 20130612
NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01 TG United, Inc. Class II Terminated 20130612
ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01 TG United, Inc. Class II Terminated 20130612
Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste B, Richland, MS 39218, NDC 23359-024-10 TG United, Inc. Class II Terminated 20130612
AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01 TG United, Inc. Class II Terminated 20130612
AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01 TG United, Inc. Class II Terminated 20130612