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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 16,721–16,740 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

TESTOSTERONE PROPIONATE 100 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/ML, 20 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

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Drug Recall Terminated Historical recordClass II

TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

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Drug Recall Terminated Historical recordClass II

SODIUM PHOSPHATE MONOBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 12 capsule bottles, Manufactured For: BeaMonstar Products Queen Creek, AZ

by Beamonstar Products

Reason
Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug
Recall initiated
May 1, 2013
Reported by FDA
September 11, 2013
Distribution
US states nationwide and international.

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Drug Recall Terminated Historical recordClass I

SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ

by Beamonstar Products

Reason
Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug
Recall initiated
May 1, 2013
Reported by FDA
September 11, 2013
Distribution
US states nationwide and international.

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Drug Recall Terminated Historical recordClass II

CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11

by Teva Pharmaceuticals USA, Inc.

Reason
Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
Recall initiated
August 13, 2013
Reported by FDA
September 11, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12

by Hospira Inc.

Reason
Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
Recall initiated
August 16, 2013
Reported by FDA
September 4, 2013
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01

by Hospira, Inc.

Reason
Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.
Recall initiated
August 12, 2013
Reported by FDA
September 4, 2013
Distribution
Naitonwide

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Drug Recall Terminated Historical recordClass II

Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals Inc, Lincolnshire, IL 60069, NDC 14789-300-02

by Nexus Pharmaceuticals Inc

Reason
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
Recall initiated
August 1, 2013
Reported by FDA
September 4, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03

by Teva Pharmaceuticals USA, Inc.

Reason
Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.
Recall initiated
August 6, 2013
Reported by FDA
September 4, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - 1.7 mL minimum each, NDC #s: a) Octocaine 100, Mfr'ed for Septodont, Louisville, CO, 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3, 0362-9023-05; b) Superdent, Dist by: Darby Dental Supply Co., Jericho, NY 11753, Made in Canada, 66467-9730-5; and c) Dist by: IQ Dental, 353 Rt 46 W, Bldg C Unit 120, Fairfield, NJ, 07004, made in Canada, 42756-1030-5; Manufactured by: by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3.

by Novocol Pharmaceutical of Canada

Reason
Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.
Recall initiated
August 14, 2013
Reported by FDA
September 4, 2013
Distribution
Nationwide and Canada

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Drug Recall Terminated Historical recordClass I

0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23

by Hospira Inc.

Reason
Presence of Particulate Matter; product may contain fibrous material
Recall initiated
August 31, 2012
Reported by FDA
September 4, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York

by Bethel Nutritional Consulting, Inc

Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug.
Recall initiated
June 11, 2013
Reported by FDA
September 4, 2013
Distribution
Nationwide. Product was also available for sale via internet

View recall →

Drug Recall Terminated Historical recordClass I

Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50

by Fresenius Kabi USA, LLC

Reason
Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
Recall initiated
May 25, 2013
Reported by FDA
September 4, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9.

by Advance Pharmaceutical Inc

Reason
Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets.
Recall initiated
June 17, 2013
Reported by FDA
September 4, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA

by Clinical Specialties Compounding Pharmacy

Reason
Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
March 11, 2013
Reported by FDA
September 4, 2013
Distribution
FL, GA, IN, LA and SC.

View recall →

Drug Recall Terminated Historical recordClass III

buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.

by Actavis South Atlantic LLC

Reason
Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.
Recall initiated
August 21, 2013
Reported by FDA
September 4, 2013
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771

by VistaPharm, Inc.

Reason
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Recall initiated
July 4, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide.

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.