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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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Drug Recall Terminated Historical recordClass II

FLECAINIDE ACETATE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054001125.

by Aidapak Services, LLC

Reason: Labeling: Label Mixup: FLECAINIDE ACETATE, Tablet, 100 mg may be potentially mislabeled as the following drug: COLESTIPOL HCL MICRONIZED, Tablet, 1 g, NDC 59762045001, Pedigree: AD56847_1, 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.

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Drug Recall Terminated Historical recordClass II

DRONEDARONE HCL, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00024414260.

by Aidapak Services, LLC

Reason: Labeling: Label Mixup: DRONEDARONE HCL, Tablet, 400 mg may be potentially as the following drug: METHYLERGONOVINE MALEATE, Tablet, 0.2 mg, NDC 43386014028, Pedigree: AD52778_40, 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

TOLTERODINE TARTRATE ER, Capsule, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00009519101.

by Aidapak Services, LLC

Reason: Labeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 4 mg may be potentially mislabeled as one of the following drugs: HYDRALAZINE HCL, Tablet, 25 mg, NDC 50111032701, Pedigree: AD49610_4, EXP: 5/16/2014; PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, 0 mg, NDC 51991056601, Pedigree: AD73597_1, EXP: 5/31/2014.
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

sitaGLIPtin PHOSPHATE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006011231.

by Aidapak Services, LLC

Reason: Labeling: Label Mixup: sitaGLIPtin PHOSPHATE, Tablet, 50 mg may be potentially mis-labeled as one of the following drugs: LACTOBACILLUS, Tablet, 0 mg, NDC 64980012950, Pedigree: AD62992_1, EXP: 5/23/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: W002860, EXP: 6/7/2014.
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

NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga , ON, UPC 0 58478 05103 1. Also packaged under foreign labels: Theraflu Extra Cold and Flu powder packets, Lemon flavor, 10-count packets per box, UPC 4 607045 191395 (Russia and Former Soviet Union product); Theraflu Nighttime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, UPC 8 806536 013925 (Korea product);

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

NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 20mg, chlorpheniramine maleate 4 mg, ascorbic acid 5 mg) powder packets, Soothing Lemon flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada Inc., Mississauga, ON, labeled as a) NeoCitran Extra Strength Nighttime Total 7 Symptom Relief (UPC 0 58478 10063 0) and b) NeoCitran Extra Strength Cough, Cold & Flu (UPC 0 58478 47363 5).

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

HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.

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

TRI-BUFFERED ASPIRIN, Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904201559.

by Aidapak Services, LLC

Reason: Labeling: Label Mixup: TRI-BUFFERED ASPIRIN, Tablet, 325 mg may have potentially been mislabeled as the following drug: ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP, Capsule, 65 mg/100 mg/325 mg, NDC 44183044001, Pedigree: W003596, EXP: 5/31/2014.
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

NIACIN TR, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904062960.

by Aidapak Services, LLC

Reason: Labeling: Label Mixup: NIACIN TR, Capsule, 250 mg may have potentially been mislabeled as the following drug: METHYLERGONOVINE MALEATE, Tablet, 0.2 mg, NDC 43386014028, Pedigree: W003477, 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

AMANTADINE HCL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00832011100.

by Aidapak Services, LLC

Reason: Labeling: Label Mixup: AMANTADINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68585000575, Pedigree: AD52993_4, EXP: 5/17/2014; QUEtiapine FUMARATE, Tablet, 25 mg, NDC 65862048901, Pedigree: AD49582_22, EXP: 4/30/2014.
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

TACROLIMUS, Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781210301.

by Aidapak Services, LLC

Reason: Labeling: Label Mixup: TACROLIMUS, Capsule, 1 mg may have potentially been mislabeled as one of the following drugs: BISOPROLOL FUMARATE, Tablet, 5 mg, NDC 29300012601, Pedigree: AD34934_7, EXP: 5/10/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD56917_4, EXP: 5/21/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD73627_11, EXP: 5/30/2014; ATOMOXE
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

AMANTADINE HCL, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781204801.

by Aidapak Services, LLC

Reason: Labeling: Label Mixup: AMANTADINE HCL, Capsule, 100 mg may have potentially been mislabeled as one of the following drugs: ACARBOSE, Tablet, 25 mg, NDC 00054014025, Pedigree: W002725, EXP: 6/6/2014; clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: W002998, EXP: 6/11/2014; ASPIRIN EC DR, Tablet, 81 mg, NDC 49348098015, Pedigree: W003672, EXP: 2/28/2014; NIACIN TR, Capsule, 500 mg, N
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 III

Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.V. infusion only, No latex, No preservative, Made in Ireland, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-3150-84

by Pfizer Inc.

Reason: Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.
Recall initiated: January 2, 2014
Reported by FDA: January 22, 2014
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.

by Novartis Consumer Health

Reason: Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Recall initiated: May 15, 2013
Reported by FDA: January 22, 2014
Distribution: Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.

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Drug Recall Terminated Historical recordClass III

Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-6438-24), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.

by Novartis Consumer Health

Reason: Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Recall initiated: May 15, 2013
Reported by FDA: January 22, 2014
Distribution: Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.

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Drug Recall Terminated Historical recordClass III

Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Novartis, distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2081-24

by Novartis Consumer Health

Reason: Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Recall initiated: May 15, 2013
Reported by FDA: January 22, 2014
Distribution: Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.

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Drug Recall Terminated Historical recordClass III

Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2084-24.

by Novartis Consumer Health

Reason: Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Recall initiated: May 15, 2013
Reported by FDA: January 22, 2014
Distribution: Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.

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Drug Recall Terminated Historical recordClass III

Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula *includes antihistamine, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2081-24.

by Novartis Consumer Health

Reason: Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Recall initiated: May 15, 2013
Reported by FDA: January 22, 2014
Distribution: Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.

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Drug Recall Terminated Historical recordClass II

PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMACEUTICALS INC, 9841 Washingtonian Blvd, Gaithersburg, MD 20878 NDC 54482-301-01

by Sigma-Tau Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility: Sigma-Tau PharmaSource, Inc. is conducting a voluntary recall of five lots of Oncaspar Injection, because of a crack under the crimp seal which caused a leak.
Recall initiated: November 1, 2013
Reported by FDA: January 22, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

HYOSCYAMINE SULFATE SL Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 76439030910

by Aidapak Services, LLC

Reason: Labeling:Label Mixup; HYOSCYAMINE SULFATE SL Tablet, 0.125 mg may be potentially mislabeled as azaTHIOprine, Tablet, 50 mg, NDC 00054408425, Pedigree: AD56832_1, EXP: 5/21/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W003464, EXP: 6/20/2014.
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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Data last updated: October 2, 2026 ET

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.