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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 15,281–15,300 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass I

Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.

by Deseo Rebajar

Reason
Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.
Recall initiated
November 7, 2013
Reported by FDA
May 7, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11

by Baxter Healthcare Corp.

Reason
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Recall initiated
February 11, 2014
Reported by FDA
May 7, 2014
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass I

Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311

by B. Braun Medical Inc

Reason
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recall initiated
November 21, 2013
Reported by FDA
May 7, 2014
Distribution
Nationwide, Puerto Rico and Spain

View recall →

Drug Recall Terminated Historical recordClass I

ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1915-07

by B. Braun Medical Inc

Reason
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recall initiated
November 21, 2013
Reported by FDA
May 7, 2014
Distribution
Nationwide, Puerto Rico and Spain

View recall →

Drug Recall Terminated Historical recordClass I

TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-9341-55

by B. Braun Medical Inc

Reason
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recall initiated
November 21, 2013
Reported by FDA
May 7, 2014
Distribution
Nationwide, Puerto Rico and Spain

View recall →

Drug Recall Terminated Historical recordClass I

15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy Bulk Package, Not For Direct Infusion, For Intravenous Use, Sterile, Single Dose Container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-3200-55

by B. Braun Medical Inc

Reason
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recall initiated
November 21, 2013
Reported by FDA
May 7, 2014
Distribution
Nationwide, Puerto Rico and Spain

View recall →

Drug Recall Terminated Historical recordClass I

6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dose container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-9350-55

by B. Braun Medical Inc

Reason
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recall initiated
November 21, 2013
Reported by FDA
May 7, 2014
Distribution
Nationwide, Puerto Rico and Spain

View recall →

Drug Recall Terminated Historical recordClass I

0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, Sterile, Single Dose Container, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-4000-55

by B. Braun Medical Inc

Reason
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recall initiated
November 21, 2013
Reported by FDA
May 7, 2014
Distribution
Nationwide, Puerto Rico and Spain

View recall →

Drug Recall Terminated Historical recordClass I

Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container, Catalog Number 3105-11, Rx Only, B Braun Medical Inc., Irvine CA 92614, NDC 0264-3105-11

by B. Braun Medical Inc

Reason
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recall initiated
November 21, 2013
Reported by FDA
May 7, 2014
Distribution
Nationwide, Puerto Rico and Spain

View recall →

Drug Recall Terminated Historical recordClass I

Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Container, Catalog Number 3103-11, For IV Use Only, Sterile, Single Dose, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3103-11

by B. Braun Medical Inc

Reason
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recall initiated
November 21, 2013
Reported by FDA
May 7, 2014
Distribution
Nationwide, Puerto Rico and Spain

View recall →

Drug Recall Terminated Historical recordClass I

Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container, Catalog Number 3193-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3193-11

by B. Braun Medical Inc

Reason
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recall initiated
November 21, 2013
Reported by FDA
May 7, 2014
Distribution
Nationwide, Puerto Rico and Spain

View recall →

Drug Recall Terminated Historical recordClass I

Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog Number 3153-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895

by B. Braun Medical Inc

Reason
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recall initiated
November 21, 2013
Reported by FDA
May 7, 2014
Distribution
Nationwide, Puerto Rico and Spain

View recall →

Drug Recall Terminated Historical recordClass I

0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1800-31

by B. Braun Medical Inc

Reason
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recall initiated
November 21, 2013
Reported by FDA
May 7, 2014
Distribution
Nationwide, Puerto Rico and Spain

View recall →

Drug Recall Terminated Historical recordClass I

Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Use Only, Single Use, Sterile, Rx Only, B Braun Medical Inc, Irvine CA 92614-5895, NDC 0264-3123-11

by B. Braun Medical Inc

Reason
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recall initiated
November 21, 2013
Reported by FDA
May 7, 2014
Distribution
Nationwide, Puerto Rico and Spain

View recall →

Drug Recall Terminated Historical recordClass I

Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regulations and applicable law. Potency 5489.6IU/mg. Packed by Medisca, Inc. Irving, TX, 75063, USA NDC 38779-2673-1, NDC 38779-2673-2, and NDC 38779-2673-6. Lot Numbers 101751/A, Exp: 05/16, CAS: 9002-61-3; 101752/A, Exp: 05/16, CAS 9002-61-3; and 101799/A, Exp: 05/16, CAS: 9002-61-3

by Medisca Inc.

Reason
Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.
Recall initiated
October 21, 2013
Reported by FDA
May 7, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden Circle, Bethlehem, PA 18017. NDC: 66794-015-25.

by Piramal Critical Care, Inc.

Reason
Failed pH Specifications: product was too acidic.
Recall initiated
April 7, 2014
Reported by FDA
May 7, 2014
Distribution
To wholesale distributors and retailers located Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.

by John W Hollis Inc

Reason
Presence of Particulate Matter
Recall initiated
March 17, 2014
Reported by FDA
May 7, 2014
Distribution
MO, TN, MS, WI

View recall →

Drug Recall Terminated Historical recordClass III

Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.

by John W Hollis Inc

Reason
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Recall initiated
March 17, 2014
Reported by FDA
May 7, 2014
Distribution
MO, TN, MS, WI

View recall →

Drug Recall Terminated Historical recordClass III

Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 mL Vial, Rx Only. Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.

by John W Hollis Inc

Reason
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Recall initiated
March 17, 2014
Reported by FDA
May 7, 2014
Distribution
MO, TN, MS, WI

View recall →

Drug Recall Terminated Historical recordClass II

Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.

by John W Hollis Inc

Reason
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Recall initiated
March 17, 2014
Reported by FDA
May 7, 2014
Distribution
MO, TN, MS, WI

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.