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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 17,341–17,360 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Recall initiated
February 26, 2013
Reported by FDA
May 15, 2013
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Recall initiated
February 26, 2013
Reported by FDA
May 15, 2013
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5552-3.

by Noven Pharmaceuticals, Inc.

Reason
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Recall initiated
January 31, 2013
Reported by FDA
May 8, 2013
Distribution
Nationwide and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

"Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas); Mint, a)12 oz bottle (NDC 0363-0073-02), b) 26 oz. bottle (NDC 0363-0073-26), Distributed by Walgreens CO., 200 Wilmot Rd, Deerfield, IL 60015.

by Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals

Reason
Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.
Recall initiated
March 16, 2013
Reported by FDA
May 8, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, NDC 63824-711-98, OTC, Dist. by: Reckitt Benckiser, Parsippany, NJ 07054

by Reckitt Benckiser Inc

Reason
Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.
Recall initiated
March 18, 2013
Reported by FDA
May 8, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Recall initiated
August 28, 2012
Reported by FDA
May 8, 2013
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Recall initiated
August 28, 2012
Reported by FDA
May 8, 2013
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Benjamins Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 mg; Sodium Bicarbonate BP, 100.0 mg; Sucrose, 487.5 mg; Alcohol, 0.362 mL; Fennel Oil BP, 0.004 mL; Dill Oil BP, 0.005 mL), 120 mL bottle, Manufactured by: P.A. Benjamin Manufacturing Co. Ltd., 97 East Street, Kingston, JAMAICA; UPC 0 83276 34324 8.

by Carib Import & Export, Inc.

Reason
CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices.
Recall initiated
February 4, 2013
Reported by FDA
May 8, 2013
Distribution
Nationwide, Bahamas, and Turks & Caicos Islands

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Drug Recall Terminated Historical recordClass II

Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmaceutical, 435 Industrial Way West, Eatontown, NJ 07724 Manufactured For: PBM Pharmaceuticals, Inc. Gordonsville, VA 22942.

by West-Ward Pharmaceutical Corp.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013.
Recall initiated
March 18, 2013
Reported by FDA
May 8, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866

by Warner Chilcott Company LLC

Reason
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Recall initiated
February 15, 2013
Reported by FDA
May 8, 2013
Distribution
US Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.

by Warner Chilcott Company LLC

Reason
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Recall initiated
February 15, 2013
Reported by FDA
May 8, 2013
Distribution
US Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866

by Warner Chilcott Company LLC

Reason
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Recall initiated
February 15, 2013
Reported by FDA
May 8, 2013
Distribution
US Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.

by Hi-Tech Pharmacal Co., Inc.

Reason
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Recall initiated
March 11, 2013
Reported by FDA
May 8, 2013
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians Total Care, Tulsa, OK 74146; Mfg. By: Novartis Consumer Health I, Lincoln, NE 68581; NDC 54868-4710-0, Barcode 47101006IHD.

by Physicians Total Care, Inc.

Reason
Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25 mg, the generic form.
Recall initiated
May 23, 2011
Reported by FDA
May 8, 2013
Distribution
FL

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Drug Recall Terminated Historical recordClass II

Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90

by Jubilant Cadista Pharmaceuticals Inc.

Reason
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
Recall initiated
February 11, 2013
Reported by FDA
May 8, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/ 4 fl oz bottle, Distributed by Laboratorios Nordimex Co., San Diego, CA 92154, UPC 0 91965 02001 1.

by OPMX, LLC

Reason
Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.
Recall initiated
April 12, 2013
Reported by FDA
May 1, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tablets per carton, Distributed by: Laboratorios Norimex Co., San Diego, CA 92154, UPC 0 91965 02002 8.

by OPMX, LLC

Reason
Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.
Recall initiated
April 12, 2013
Reported by FDA
May 1, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.

by Qualitest Pharmaceuticals

Reason
Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.
Recall initiated
April 19, 2013
Reported by FDA
May 1, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

by Hospira Inc.

Reason
Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
Recall initiated
April 8, 2013
Reported by FDA
May 1, 2013
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

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.
Recall initiated
April 17, 2013
Reported by FDA
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.