Skip to main content
Get Alerts

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 11,381–11,400 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue

by North American Rescue LLC.

Reason
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Recall initiated
September 27, 2016
Reported by FDA
December 14, 2016
Distribution
Nationwide, Australia & Switzerland

View recall →

Drug Recall Terminated Historical recordClass II

Range Trauma Kit - Product Code 85-1274, North American Rescue

by North American Rescue LLC.

Reason
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Recall initiated
September 27, 2016
Reported by FDA
December 14, 2016
Distribution
Nationwide, Australia & Switzerland

View recall →

Drug Recall Terminated Historical recordClass II

Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue

by North American Rescue LLC.

Reason
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Recall initiated
September 27, 2016
Reported by FDA
December 14, 2016
Distribution
Nationwide, Australia & Switzerland

View recall →

Drug Recall Terminated Historical recordClass II

Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue

by North American Rescue LLC.

Reason
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Recall initiated
September 27, 2016
Reported by FDA
December 14, 2016
Distribution
Nationwide, Australia & Switzerland

View recall →

Drug Recall Terminated Historical recordClass II

PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Recall initiated
November 2, 2016
Reported by FDA
December 14, 2016
Distribution
NY

View recall →

Drug Recall Terminated Historical recordClass II

PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Recall initiated
November 2, 2016
Reported by FDA
December 14, 2016
Distribution
NY

View recall →

Drug Recall Terminated Historical recordClass III

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only, Mfd: Hikma Farmaceutica (Portugal,) SA Distributed by: Westward Eatowntown NJ 07724 USA, Shelf pack NDC 0143-9570-10, Unit dose NDC 0143-9570-01

by West-Ward Pharmaceuticals Corp.

Reason
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Recall initiated
November 17, 2016
Reported by FDA
December 14, 2016
Distribution
US nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-210-13.

by Teva Pharmaceuticals USA

Reason
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Recall initiated
November 1, 2016
Reported by FDA
December 14, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-206-06 and 59310-206-08 (Physician Samples).

by Teva Pharmaceuticals USA

Reason
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Recall initiated
November 1, 2016
Reported by FDA
December 14, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01

by Hospira Inc.

Reason
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
Recall initiated
June 29, 2016
Reported by FDA
December 14, 2016
Distribution
US and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.

by Nationwide Laboratories, LLC

Reason
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Recall initiated
October 28, 2016
Reported by FDA
December 7, 2016
Distribution
Nationwide in USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.

by Nationwide Laboratories, LLC

Reason
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Recall initiated
October 28, 2016
Reported by FDA
December 7, 2016
Distribution
Nationwide in USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bottles (NDC 42937-704-18); and c) 1000 count bottles (NDC 42937-704-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.

by Nationwide Laboratories, LLC

Reason
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Recall initiated
October 28, 2016
Reported by FDA
December 7, 2016
Distribution
Nationwide in USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000 count bottles (NDC 42937-703-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.

by Nationwide Laboratories, LLC

Reason
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Recall initiated
October 28, 2016
Reported by FDA
December 7, 2016
Distribution
Nationwide in USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002

by Cadila Pharmaceuticals Limited

Reason
Microbial Contamination of Non-Sterile Product
Recall initiated
September 9, 2016
Reported by FDA
December 7, 2016
Distribution
According to the firm, the API distributed to two consignees in the US. See Consignee list below. Consignee List: 1). LLC LENS Phanna. Russia 2). Claris irljectable, Ahmedabad 3). CPL. Inc, USA

View recall →

Drug Recall Terminated Historical recordClass II

Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10

by Ascend Laboratories LLC

Reason
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Recall initiated
November 2, 2016
Reported by FDA
December 7, 2016
Distribution
AL, FL, GA, SC & TN

View recall →

Drug Recall Terminated Historical recordClass II

Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10

by Burel Pharmaceuticals Inc

Reason
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Recall initiated
October 24, 2016
Reported by FDA
December 7, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10

by Burel Pharmaceuticals Inc

Reason
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Recall initiated
October 24, 2016
Reported by FDA
December 7, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue, 10 mg; Hyoscyamine Sulfate, 0.12 mg, 100 count, Rx only, Manufactured for: BUREL PHARMACEUTICALS, NDC 35573-315-10

by Burel Pharmaceuticals Inc

Reason
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Recall initiated
October 24, 2016
Reported by FDA
December 7, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10

by Burel Pharmaceuticals Inc

Reason
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Recall initiated
October 24, 2016
Reported by FDA
December 7, 2016
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.