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.

Search
By Dosage Form:
AllTabletsCapsulesInjectables
By Recall Category:
AllContamination / SterilityLabeling / PackagingUndeclared Ingredient
HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative
Date: 10/06/2014
Product: HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Company: Oregon Compounding Centers, Inc. dba Creative Compounds
Recall Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Category: Class II
View Details View FDA Recall Listings
VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured
Date: 07/08/2014
Product: VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company,  Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709  NDC 63010-027-70
Company: Pfizer Inc.
Recall Reason: Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016.  The correct expiry date is 09/2016.
Category: Class III
View Details View FDA Recall Listings
Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP,
Date: 04/11/2014
Product: Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg  (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, Lancaster, NY 14086, UPC 341520339677, B) Our Family 4 fl oz bottle, Distributed by Nash Finch Company, NFC Brands, MPLS, MN 55435, UPC 070253579523, C) Premier Value 4, 8 fl oz bottle, Distributed by Chain Drug Consortium, LLC., Boca Raton, FL 33431, 4 fl oz UPC 840986024719;  8 fl oz UPC 840986024726, NDC 68016-177-XX,  D) Rexall  4 fl oz bottle, Packaged for Dolencorp, LLC, Goodlettsville, TN 37072, UPC 715256714044, E) Safeway  4 fl oz, Distributed by Safeway INC, Pleasanton, CA 94566-0009, UPC 321130763581; F) Select Brand 4, 8 fl oz, Distributed by Select Brand Distributers, Pine Bluff, AR 71603, 4 fl oz UPC 015127024303; 8 fl oz UPC 015127024310.
Company: Aaron Industries Inc
Recall Reason: Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
Category: Class III
View Details View FDA Recall Listings
Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward
Date: 11/07/2013
Product: Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets.  Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10.
Company: West-Ward Pharmaceutical Corp.
Recall Reason: Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Category: Class II
View Details View FDA Recall Listings
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
View Details View FDA Recall Listings
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
View Details View FDA Recall Listings
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
View Details View FDA Recall Listings
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
View Details View FDA Recall Listings
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
View Details View FDA Recall Listings
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
View Details View FDA Recall Listings
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
View Details View FDA Recall Listings
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
View Details View FDA Recall Listings
« Previous
1
…
7
8
9
10
Next »