Drug Recall Records

This page shows recent human drug recall alerts sourced from the FDA. It includes current and some previously imported records, but is not a complete historical archive of all past recalls. For full historical data, visit the official FDA Drug Recalls page. Always consult a healthcare professional for medical advice.

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AllContamination / SterilityLabeling / PackagingUndeclared Ingredient
Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous
Date: 09/13/2013
Product: Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4496-22
Company: AmeriSource Bergen
Recall Reason: Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
Category: Class II
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FLUCONAZOLE, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC
Date: 07/02/2013
Product: FLUCONAZOLE, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00172541360.
Company: Aidapak Services, LLC
Recall Reason: Labeling: Label Mixup: FLUCONAZOLE, Tablet, 200 mg may have potentially been mislabeled as one of the following drugs:  VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD65475_10, EXP: 5/28/2014;  FLUCONAZOLE, Tablet, 100 mg, NDC 68462010230, Pedigree: W003064, EXP: 6/12/2014.
Category: Class II
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VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, Over The Counter, Distributed by:
Date: 07/02/2013
Product: VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258016001
Company: Aidapak Services, LLC
Recall Reason: Labeling:Label Mixup; VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet may be potentially mislabeled as    LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: AD73652_10, EXP: 5/30/2014;  HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, NDC 43199001401, Pedigree: W003576, EXP: 6/24/2014;  MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD70655_14, EXP: 5/28/2014;  MELATONIN, Tablet, 3 mg, NDC
Category: Class II
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FAMOTIDINE Tablet, 20 mg, Over The Counter, Distributed by: AidaPak Service, LLC,
Date: 07/02/2013
Product: FAMOTIDINE Tablet, 20 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 16714036104
Company: Aidapak Services, LLC
Recall Reason: Labeling: Label Mixup; FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as    CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, NDC 00007337113, Pedigree: W003225, EXP: 6/17/2014;  DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003506, EXP: 6/21/2014;  FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003507, EXP: 6/21/2014;  MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 0037822500
Category: Class II
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NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10
Date: 06/18/2013
Product: NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga , ON, UPC 0 58478 05103 1.    Also packaged under foreign labels:   Theraflu Extra Cold and Flu powder packets, Lemon flavor, 10-count packets per box, UPC 4 607045 191395 (Russia and Former Soviet Union product); Theraflu Nighttime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, UPC 8 806536 013925 (Korea product);
Company: Novartis Consumer Health
Recall Reason: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Category: Class II
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Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65
Date: 06/06/2013
Product: Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203 702     Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin 250 mg and 65 mg Caffeine) 2-ct pouches.  The foreign packaging do not have NDC numbers
Company: Novartis Consumer Health
Recall Reason: Defective container: products are packaged in pouches which may not have been fully sealed
Category: Class II
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Mic Ultra-Sulfur Free 30ml, Main Street Compounding Pharmacy, 126 East Main Street,
Date: 05/28/2013
Product: Mic Ultra-Sulfur Free 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Company: Main Street Family Pharmacy, LLC
Recall Reason: The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Category: Class II
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Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile,
Date: 05/20/2013
Product: Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045.
Company: Hospira, Inc.
Recall Reason: Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
Category: Class II
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Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare
Date: 04/17/2013
Product: Trimix  Customs Injectable  Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Company: Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Recall Reason: Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this  compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Category: Class II
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Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson
Date: 03/22/2013
Product: Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)
Company: Actavis Inc
Recall Reason: Failed Tablet/Capsule Specifications: Broken tablets
Category: Class II
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Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA
Date: 03/20/2013
Product: Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Company: Clinical Specialties Compounding Pharmacy
Recall Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Category: Class II
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AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle,
Date: 01/30/2013
Product: AMBI 2CPM/15DM/5PEH, Antihistamine,  Nasal Decongestant,  Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.
Company: TG United, Inc.
Recall Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Category: Class II
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