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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

ATOMOXETINE HCL, Capsule, 18 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323830.

by Aidapak Services, LLC

Reason: Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 18 mg, may be potentially mis-labeled as the following drug: LOVASTATIN, Tablet, 20 mg, NDC 00185007201, Pedigree: AD28369_1, EXP: 5/7/2014.
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

DULoxetine HCl DR, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323560.

by Aidapak Services, LLC

Reason: Labeling: Label Mixup: DULoxetine HCl DR, Capsule, 20 mg, may be potentially mis-labeled with one of the following drugs: ENTECAVIR, Tablet, 0.5 mg, NDC 00003161112, Pedigree: AD30140_28, EXP: 5/7/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD54587_1, EXP: 5/21/2014; FLUoxetine HCl, Capsule, 10 mg , NDC 16714035103, Pedigree: AD70585_13, EXP: 5/29/2014; CHOLECALCIFEROL
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

ATOMOXETINE HCL, Capsule, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002322930.

by Aidapak Services, LLC

Reason: Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 40 mg may be potentially mis-labeled as OLANZAPINE, Tablet, 7.5 mg, NDC 60505311203, Pedigree: AD21790_76, EXP: 5/1/2014; ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD46265_19, EXP: 5/15/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD60272_79, EXP: 5/22/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD73
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 I

Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA

by Cubist Pharmaceuticals, Inc.

Reason: Presence of Particulate Matter; Glass particulates observed in vials
Recall initiated: August 29, 2013
Reported by FDA: January 29, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berries flavor, 10-count packets per box, UPC 4 607045 191760. (Russian product and Former Soviet Union 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 Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05703 3. Also packaged under foreign label: Theraflu Daytime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7116-06, UPC 8 806536 01402 1 (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 DM Cough & Cold (dextromethorphan hydrobromide 30 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 05503 9.

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 (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg) powder packets, Natural Source Cherry flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, labeled as a) NeoCitran Ultra Strength Total Flu 7 Symptom Relief (UPC 0 58478 47365 9) and b) NeoCitran Extra Strength Sore Throat & Cough (UPC 0 58478 47365 9).

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 Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon Infused with Chamomille & White Tea flavors, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6256-06, UPC 3 0043-6256-06. Also packaged under foreign label: NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, diphenhydramine hydrochloride 25 mg, Soothing Honey Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., UPC 0 58478 10594 9.

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 & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-0483-06, UPC 3 0043-0483-06 1.

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 Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6318-06, UPC 3 0043-6318-06 0.

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 MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6427-06, UPC 3 0067-6427-06 5. Also packaged under foreign label: NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief powder packets, Soothing Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 10701 1.

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 Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Green Tea & Honey Lemon flavors, packaged in a) 6-count packets per carton (NDC 0067-6426-06, UPC 3 0067-6426-06 8) and b) 1-count packet per card (NDC 0067-6426-01, UPC 3 0067-6426-01 3), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.

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 (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, labeled as a) Theraflu Sinus & Cold (NDC 0067-6319-06, UPC 3 0043-6319-06 7) and b) Theraflu Cold & Sore Throat (NDC 0067-6716-06, UPC 3 0043-0467-16 0). Also packaged under foreign labels: NeoCitran Cold & Flu powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05009 6; and Theraflu Exthegran powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812904) and b) 10-count packets per carton (UPC 7 501124 814588), 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 Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol & Green Tea flavors and Nighttime formula (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, and phenylephrine hydrochloride 10 mg), Honey Lemon Infused with Chamomile & White Tea flavors; packaged in a) 24-count packets per carton containing 6-count Daytime and 18-count Nighttime packets (UPC 3 0043-6403-24 7); b) 12-count packets per carton containing 6-count Daytime and 6-count Nighttime packets (UPC 3 0043-6403-12 4); Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.

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 Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Berry Infused with Menthol & Green Tea flavors, 6-count packets per carton, , Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6257-06, UPC 3 0043-6257-06 2. Also packaged under foreign label: NeoCitran Extra Strength Daytime Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, dextromethorphan hydrobromide 20 mg) powder packets, Invigorating Berry with Green Tea flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada Inc., Mississauga, ON, UPC 0 58478 10366 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 III

Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA. NDC: 0093-5414-95.

by Teva Pharmaceuticals USA, Inc.

Reason: Failed Stability Specifications: this product is below specification for preservative content.
Recall initiated: November 14, 2013
Reported by FDA: January 29, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Distributed by: Greenstone LLC, Peapack, NJ 07977 -- MADE IN INDIA --- NDC 59762-4960-1

by Greenstone Llc

Reason: Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36 month shelf life, instead of the 24 month shelf life
Recall initiated: November 5, 2013
Reported by FDA: January 29, 2014
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

by Hospira Inc.

Reason: Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.
Recall initiated: December 12, 2013
Reported by FDA: January 29, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-011-01, 500 count NDC: 10702-011-50, 1000 count NDC: 10702-011-10.

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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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.