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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 15,561–15,580 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

PHENOL, LOZENGE, 29 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00068021918.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup: PHENOL, LOZENGE, 29 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 20 mg, NDC 00378201777, Pedigree: AD49582_10, EXP: 5/16/2014; VITAMIN B COMPLEX W/C, Tablet, 0 mg, NDC 00904026013, Pedigree: AD60240_48, EXP: 5/22/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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Drug Recall Terminated Historical recordClass II

MERCapsuleTOPURINE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054458111.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup: MERCapsuleTOPURINE, Tablet, 50 mg may have potentially been mislabeled as the following drug: ASCORBIC ACID, Tablet, 500 mg, NDC 00904052380, Pedigree: AD54576_4, EXP: 5/20/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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Drug Recall Terminated Historical recordClass II

ACARBOSE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054014025.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup: ACARBOSE, Tablet, 25 mg may be potentially mislabeled as one of the following drugs: ZINC GLUCONATE, Tablet, 50 mg, NDC 00904319160, Pedigree: AD60240_57, EXP: 5/22/2014; TOLTERODINE TARTRATE ER, Capsule, 2 mg, NDC 00009519001, Pedigree: W002724, EXP: 6/6/2014; SILDENAFIL CITRATE, Tablet, 25 mg, NDC 00069420030, Pedigree: W003646, EXP: 6/25/2014; SEVELAMER CARBONATE, Tab
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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Drug Recall Terminated Historical recordClass II

EXEMESTANE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054008013.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup: EXEMESTANE, Tablet, 25 mg may be potentially mislabeled as the following drug: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003473, EXP: 6/20/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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Drug Recall Terminated Historical recordClass II

LITHIUM CARBONATE ER, Tablet, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054002125.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 300 mg may be potentially mislabled as the following drug: VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg, NDC 40985022251, Pedigree: AD39588_10, EXP: 5/13/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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Drug Recall Terminated Historical recordClass II

CALCITRIOL, Capsule, 0.25 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054000725.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup: CALCITRIOL, Capsule, 0.25 mcg may be potentially as one of the following drugs: ANAGRELIDE HCL, Capsule, 0.5 mg, NDC 00172524160, Pedigree: AD46414_7, EXP: 5/16/2014; BENAZEPRIL HCL, Tablet, 5 mg, NDC 65162075110, Pedigree: AD52778_7, EXP: 5/20/2014; CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: W003615, EXP: 6/25/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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Drug Recall Terminated Historical recordClass II

SIROLIMUS, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00008104105.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup: SIROLIMUS, Tablet, 1 mg may be potentially mislabeled as one of the following drugs: PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD60272_34, EXP: 5/22/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W003325, EXP: 6/18/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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Drug Recall Terminated Historical recordClass II

MYCOPHENOLATE MOFETIL, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00004025901.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may be potentially mis-labeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD52412_11, EXP: 5/17/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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Drug Recall Terminated Historical recordClass II

RALOXIFENE HCL, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002416530.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup: RALOXIFENE HCL, Tablet, 60 mg may be potentially mis-labeled as following drug: ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701; Pedigree: W002656, EXP: 6/4/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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Drug Recall Terminated Historical recordClass II

Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812881) and b) 10-count packets per carton (UPC 7 501124 814595), Distributed by Novartis Farmaceutica, S.A., DE C.V., Mexico.

by Novartis Consumer Health

Reason
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Recall initiated
June 18, 2013
Reported by FDA
January 29, 2014
Distribution
Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.

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Drug Recall Terminated Historical recordClass II

Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Apple Cinnamon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7916-06, UPC 3 0043-0479-16 3. Also packaged under foreign label: NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Apple Cinnamon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05205 2.

by Novartis Consumer Health

Reason
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Recall initiated
June 18, 2013
Reported by FDA
January 29, 2014
Distribution
Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.

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Drug Recall Terminated Historical recordClass II

Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA; for Nexus Pharmaceuticals Inc; Vernon Hills, IL 60061. NDC 14789-500-10.

by Fresenius Kabi USA, LLC

Reason
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
Recall initiated
October 31, 2013
Reported by FDA
January 29, 2014
Distribution
US: Nationwide

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Drug Recall Terminated Historical recordClass II

HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10.

by KVK-Tech, Inc.

Reason
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Recall initiated
December 11, 2013
Reported by FDA
January 29, 2014
Distribution
Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.

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Drug Recall Terminated Historical recordClass II

SELENIUM, Tablet, 50 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904316260.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup :SELENIUM, Tablet, 50 mcg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: AD56917_13, EXP: 5/21/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

View recall →

Drug Recall Terminated Historical recordClass II

ASPIRIN EC, Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904201360.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup: ASPIRIN EC, Tablet, 325 mg may have potentially been mislabeled as one of the following drugs: MULTIVITAMIN/MULTIMINERAL, CHEW Tablet, 0 mg, NDC 58914001460, Pedigree: AD30180_10, EXP: 5/9/2014; DILTIAZEM HCL ER, Capsule, 240 mg, NDC 49884083109, Pedigree: AD52375_1, EXP: 5/17/2014; ASPIRIN, Tablet, 325 mg, NDC 00536330501, Pedigree: W003355, EXP: 6/19/2014; ASPIRIN, Tab
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

View recall →

Drug Recall Terminated Historical recordClass II

ASCORBIC ACID, Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904052380.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup: ASCORBIC ACID, Tablet, 500 mg may have potentially been mislabeled as the following drug: OXcarbazepine, Tablet, 150 mg, NDC 62756018388, Pedigree: AD54562_4, EXP: 5/20/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

View recall →

Drug Recall Terminated Historical recordClass II

ASCORBIC ACID, Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904052372.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup: ASCORBIC ACID, Tablet, 500 mg may have potentially been mislabeled as the following drug: VENLAFAXINE HCL, Tablet, 100 mg, NDC 00093738301, Pedigree: AD42566_1, EXP: 5/14/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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Drug Recall Terminated Historical recordClass II

ASCORBIC ACID, Tablet, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904052260.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup: ASCORBIC ACID, Tablet, 250 mg may have potentially been mislabeled as one of the following drugs: PREGABALIN, Capsule, 200 mg, NDC 00071101768, Pedigree: AD30024_1, EXP: 5/9/2014; NIFEDIPINE, Capsule, 10 mg, NDC 43386044024, Pedigree: AD23082_10, EXP: 9/23/2013; PIMOZIDE, Tablet, 2 mg, NDC 57844018701, Pedigree: AD30140_43, EXP: 5/7/2014; OMEGA-3-ACID ETHYL ESTERS, Capsu
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

View recall →

Drug Recall Terminated Historical recordClass II

TACROLIMUS, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781210201.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup: TACROLIMUS, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: W003168, EXP: 6/13/2014; ISOSORBIDE MONONITRATE ER, Tablet, 30 mg, NDC 62175012837, Pedigree: W003350, EXP: 6/18/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

View recall →

Drug Recall Terminated Historical recordClass II

METHAZOLAMIDE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781107101.

by Aidapak Services, LLC

Reason
Labeling: Label Mixup: METHAZOLAMIDE, Tablet, 50 mg may have potentially been mislabeled as the following drug: BUPRENORPHINE HCL SL, Tablet, 2 mg, NDC 00054017613, Pedigree: AD39573_1, EXP: 5/13/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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.