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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 7,301–7,320 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810.

by Aurolife Pharma, LLC

Reason
Failed Impurities/Degradation Specifications
Recall initiated
August 23, 2019
Reported by FDA
September 25, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cartons (NDC 62011-0315-2) HealthMart PHARMACY, Distributed by McKesson, One Post Street, San Francisco, CA 94104.

by Aurolife Pharma, LLC

Reason
Failed Impurities/Degradation Specifications
Recall initiated
August 23, 2019
Reported by FDA
September 25, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-995-62.

by Aurolife Pharma, LLC

Reason
Failed Impurities/Degradation Specifications
Recall initiated
August 23, 2019
Reported by FDA
September 25, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104.

by Aurolife Pharma, LLC

Reason
Failed Impurities/Degradation Specifications
Recall initiated
August 23, 2019
Reported by FDA
September 25, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, NDC 68196-976-91, UPC 0 78742 23550 9.

by Aurolife Pharma, LLC

Reason
Failed Impurities/Degradation Specifications
Recall initiated
August 23, 2019
Reported by FDA
September 25, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor Pharmacy, Distributed By Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-387-23.

by Aurolife Pharma, LLC

Reason
Failed Impurities/Degradation Specifications
Recall initiated
August 23, 2019
Reported by FDA
September 25, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count cartons (NDC 60000-409-30); c) 45-count bonus cartons (NDC 60000-409-48); d) 45-count cartons (NDC 60000-409-45); CAREone, Distributed by: Foodhold U.S.A., LLC, Landover, MD 20785.

by Aurolife Pharma, LLC

Reason
Failed Impurities/Degradation Specifications
Recall initiated
August 23, 2019
Reported by FDA
September 25, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21

by Aurolife Pharma, LLC

Reason
Failed Impurities/Degradation Specifications
Recall initiated
August 23, 2019
Reported by FDA
September 25, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59

by West-Ward Columbus Inc

Reason
Failed Impurities/Degradation Specificattion
Recall initiated
September 9, 2019
Reported by FDA
September 25, 2019
Distribution
Nationwide USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01.

by Torrent Pharma Inc.

Reason
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Recall initiated
September 6, 2019
Reported by FDA
September 25, 2019
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Soothing Sore Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-077-14), b) 2 Oz (NDC 69804-077-15), and c) 4 Oz (NDC 69804-077-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

by Ridge Properties, LLC

Reason
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Recall initiated
August 9, 2019
Reported by FDA
September 25, 2019
Distribution
Nationwide in the USA via internet sales through Amazon.com; ebay.com; Walmart.com; tatbalm.net; Naturallyhl.com

View recall →

Drug Recall Terminated Historical recordClass II

Soothing Sore Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-074-05), b) 2 OZ (NDC 69804-074-02), and c) 4 OZ (NDC 69804-074-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

by Ridge Properties, LLC

Reason
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Recall initiated
August 9, 2019
Reported by FDA
September 25, 2019
Distribution
Nationwide in the USA via internet sales through Amazon.com; ebay.com; Walmart.com; tatbalm.net; Naturallyhl.com

View recall →

Drug Recall Terminated Historical recordClass II

Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-073-14), b) 2 Oz (NDC 69804-073-15), and c) 4 Oz (NDC 69804-073-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

by Ridge Properties, LLC

Reason
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Recall initiated
August 9, 2019
Reported by FDA
September 25, 2019
Distribution
Nationwide in the USA via internet sales through Amazon.com; ebay.com; Walmart.com; tatbalm.net; Naturallyhl.com

View recall →

Drug Recall Terminated Historical recordClass II

Superior Pain & Itch Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-070-05), b) 2 OZ (NDC 69804-070-02), and c) 4 OZ (NDC 69804-070-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

by Ridge Properties, LLC

Reason
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Recall initiated
August 9, 2019
Reported by FDA
September 25, 2019
Distribution
Nationwide in the USA via internet sales through Amazon.com; ebay.com; Walmart.com; tatbalm.net; Naturallyhl.com

View recall →

Drug Recall Terminated Historical recordClass II

PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-019-14), b) 2 Oz (NDC 69804-019-15), and c) 4 Oz (NDC 69804-019-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

by Ridge Properties, LLC

Reason
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Recall initiated
August 9, 2019
Reported by FDA
September 25, 2019
Distribution
Nationwide in the USA via internet sales through Amazon.com; ebay.com; Walmart.com; tatbalm.net; Naturallyhl.com

View recall →

Drug Recall Terminated Historical recordClass II

PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in a) 1 OZ (NDC 69804-002-05), b) 2 OZ (NDC 69804-002-02), and c) 4 OZ (NDC 69804-002-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

by Ridge Properties, LLC

Reason
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Recall initiated
August 9, 2019
Reported by FDA
September 25, 2019
Distribution
Nationwide in the USA via internet sales through Amazon.com; ebay.com; Walmart.com; tatbalm.net; Naturallyhl.com

View recall →

Drug Recall Terminated Historical recordClass I

Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count cartons of 10 trays x 10 unit dose cups, Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.

by Plastikon Healthcare LLC

Reason
Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
Recall initiated
August 30, 2019
Reported by FDA
September 18, 2019
Distribution
One distributor who further distributed Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.

by AVKARE Inc.

Reason
Failed Stability Specifications.
Recall initiated
August 28, 2019
Reported by FDA
September 18, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles

by Compounded Solutions in Pharmacy

Reason
Lack of Processing Controls:
Recall initiated
September 3, 2019
Reported by FDA
September 18, 2019
Distribution
Product was dispensed to patients

View recall →

Drug Recall Terminated Historical recordClass II

10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles

by Compounded Solutions in Pharmacy

Reason
Lack of Processing Controls:
Recall initiated
September 3, 2019
Reported by FDA
September 18, 2019
Distribution
Product was dispensed to patients

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.