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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 16,121–16,140 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904533260

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn) may be potentially mislabeled as PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD56916_1, EXP: 5/21/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 22, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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Drug Recall Terminated Historical recordClass II

PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904531360

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as RILUZOLE, Tablet, 50 mg, NDC 00075770060, Pedigree: AD62992_11, EXP: 5/23/2014; ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: W003093, EXP: 6/13/2014; NIACIN TR, Capsule, 250 mg, NDC 00904062960, Pedigree: W003478, EXP: 6/20/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 009045
Recall initiated
July 2, 2013
Reported by FDA
January 22, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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Drug Recall Terminated Historical recordClass II

CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium) may be potentially mislabeled as LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD46265_10, EXP: 5/15/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 22, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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Drug Recall Terminated Historical recordClass II

CALCIUM CITRATE, Tablet, 950 mg (200 MG ELEMENTAL Ca), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 MG ELEMENTAL Ca) may be potentially mislabeled as TRIMETHOBENZAMIDE HCL, Capsule, 300 mg, NDC 53489037601, Pedigree: AD21858_10, EXP: 5/1/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 22, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

View recall →

Drug Recall Terminated Historical recordClass II

CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca) may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: W002767, EXP: 6/6/2014; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 MILLION CFU, NDC 43292050022, Pedigree: AD60240_20, EXP: 5/22/2014; PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: AD73521_25, EXP: 5/30/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 22, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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Drug Recall Terminated Historical recordClass II

COENZYME Q-10, Capsule, 30 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904501546

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; COENZYME Q-10, Capsule, 30 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121201, Pedigree: W002819, EXP: 6/7/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 22, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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Drug Recall Terminated Historical recordClass II

CYANOCOBALAMIN, Tablet, 1000 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904421713

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; CYANOCOBALAMIN, Tablet, 1000 mcg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD21846_43, EXP: 5/1/2014; NIACIN TR, Capsule, 500 mg, NDC 00904063160, Pedigree: AD46257_22, EXP: 5/15/2014; chlorproMAZINE HCl, Tablet, 50 mg, NDC 00832030200, Pedigree: AD32973_4, EXP: 5/9/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC
Recall initiated
July 2, 2013
Reported by FDA
January 22, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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Drug Recall Terminated Historical recordClass II

CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904323392.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units may be potentially mis-labeled as DIGOXIN, Tablet, 125 mcg, NDC 00527132401, Pedigree: AD76675_4, EXP: 6/3/2014; or AMANTADINE HCL, Tablet, 100 mg, NDC 00832011100, Pedigree: AD54475_4, EXP: 5/20/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 22, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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Drug Recall Terminated Historical recordClass I

Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.

by Hospira Inc.

Reason
Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
Recall initiated
August 30, 2013
Reported by FDA
January 22, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 mL Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated
October 19, 2013
Reported by FDA
January 22, 2014
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass II

0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated
October 19, 2013
Reported by FDA
January 22, 2014
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass II

Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated
October 19, 2013
Reported by FDA
January 22, 2014
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass II

TROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated
October 19, 2013
Reported by FDA
January 22, 2014
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass II

TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated
October 19, 2013
Reported by FDA
January 22, 2014
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass II

TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated
October 19, 2013
Reported by FDA
January 22, 2014
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass II

Sodium tetradecyl SO4, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated
October 19, 2013
Reported by FDA
January 22, 2014
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass II

QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJECTABLE, QUAD MIX* 0.1 mg/9 mg/1 mg/10 mcg/mL INJECTABLE, SUPER QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, (pavaperine HCl, phentolamine, prostaglandin, atropine sulfate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated
October 19, 2013
Reported by FDA
January 22, 2014
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass II

Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated
October 19, 2013
Reported by FDA
January 22, 2014
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass II

Papaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 mL), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated
October 19, 2013
Reported by FDA
January 22, 2014
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass II

Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated
October 19, 2013
Reported by FDA
January 22, 2014
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.

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.