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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 15,961–15,980 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904759160

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe) may be potentially mislabeled as COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: W002711, EXP: 6/6/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: W002825, EXP: 12/31/2013; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD60236_1, EXP: 5/22/2014.
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

CHOLECALCIFEROL, Capsule, 5000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 0904598660

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; CHOLECALCIFEROL, Capsule, 5000 units may be potentially mislabeled as SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD70629_16, EXP: 5/29/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W003540, EXP: 6/21/2014; THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: AD52993_16, 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 II

CHOLECALCIFEROL, Tablet, 1000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582460

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 1000 units may be potentially mislabeled as ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: W003459, EXP: 6/20/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 37205018581, Pedigree: AD32328_8, EXP: 5/9/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002715, EXP: 6/5/2014; GLYCOPYRROLATE, Tablet, 2 mg, NDC 49884006601
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

CHOLECALCIFEROL, Tablet, 400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582360

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 400 units may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD37056_10, EXP: 5/10/2014; ROSUVASTATIN CALCIUM, Tablet, 5 mg, NDC 00310075590, Pedigree: W002567, EXP: 6/3/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD76686_4, EXP: 5/31/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 0053
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

GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904559293

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD60211_11, EXP: 5/22/2014.
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

MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904549213

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as LISINOPRIL, Tablet, 2.5 mg, NDC 64679092701, Pedigree: AD25264_4, EXP: 5/3/2014.
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

GUAIFENESIN, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904515460

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; GUAIFENESIN, Tablet, 200 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: W002850, 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

ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904513559

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be potentially mislabeled as NAPROXEN, Tablet, 500 mg, NDC 53746019001, Pedigree: AD68025_8, EXP: 5/28/2014.
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

PSEUDOEPHEDRINE HCL, Tablet, 60 mg, Rx in Oregon, Distributed by: AidaPak Service, LLC, NDC 00904512559

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 60 mg may be potentially mislabeled as REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree: W002855, 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

CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem 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 Elem Calcium) may be potentially mislabeled as tiZANidine HCL, Tablet, 2 mg, NDC 57664050289, Pedigree: W003750, EXP: 6/26/2014.
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, 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, 200 mg Elemental Calcium may be potentially mislabeled as TRIAMTERENE/HCTZ, Tablet, 37.5 mg/25 mg, NDC 00378135201, Pedigree: AD28333_4, EXP: 5/6/2014.
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

PSEUDOEPHEDRINE HCL, Tablet, 30 mg, Rx in Oregon, Distributed by: AidaPak Service, LLC, NDC 00904505360

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 30 mg may be potentially mislabeled as D-ALPHA TOCOPHERYL ACETATE, Capsule, 400 units, NDC 49348041010, Pedigree: AD52993_28, 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.

View recall →

Drug Recall Terminated Historical recordClass II

NIACIN TR, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904434260

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; NIACIN TR, Tablet, 500 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W002968, EXP: 6/11/2014.
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

OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904404360

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mis-labeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: AD33897_16, EXP: 5/9/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD33897_19, EXP: 5/9/2014; PSEUDOEPHEDRINE HCL, Tablet, 60 mg, NDC 00904512559, Pedigree: W002856, EXP: 6/7/2014; DOCUSATE SODIUM, Capsule, 50 mg, N
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

ZINC GLUCONATE, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904319160.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup; ZINC GLUCONATE, Tablet, 50 mg may be potentially mis-labeled as ASCORBIC ACID, Chew Tablet, 500 mg, NDC 00904052660, Pedigree: AD60240_54, EXP: 5/22/2014 and ASCORBIC ACID, Chew Tablet, 250 mg, NDC 00904052260, Pedigree: W003027, EXP: 6/12/2014.
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

NorthStar Arthritis Relief Cream. Net Wt. 2 oz tube, OTC, Manufactured for and Distributed by NewMarket Health Products, LLC. 702 Cathedral St. Baltimore, MD 21201

by Mariposa Labs, LLC

Reason
Microbial Contamination of Non-Sterile Products: Arthritis Relief Cream failed microbiological specifications.
Recall initiated
November 29, 2012
Reported by FDA
January 22, 2014
Distribution
One consignee who in turn sent it to one consignee

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Drug Recall Terminated Historical recordClass II

SODIUM HYDROXIDE (BAC.STATIC) 10% 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.

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Drug Recall Terminated Historical recordClass II

WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) 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

VIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 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.

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Drug Recall Terminated Historical recordClass II

VANCOMYCIN HCL 10 mg/mL 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 →

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.