Reported Jan 29, 2014 · Terminated

Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine…

Novartis Consumer Health

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Novartis Consumer Health · 10401 Hwy 6 · Lincoln, NE · 68517-9626

Is this the product you have?

  • 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 byNovartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6256-06, UPC 3 0043-6256-06
  • Also packaged under foreign labelNeoCitran 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
Lot codes and dates
    • Lot #: 1011525
    • 10115834
    • Exp 5/31/2013
    • 10116012
    • 10116043
    • 10116045
    • 10116047
    • 10116049
    • 10117462
    • 10118936 Exp 6/30/2013
    • 10118683
    • 10118685
    • 10118934
    • 10118938
    • Exp 7/31/2013
    • 10122278
    • 10122280
    • 1012282
    • Exp 8/31/2013
    • 10124331
    • 10124333
    • 10124335
    • 10125908
    • Exp 9/30/2013
    • 10125923
    • 10126909
    • 10126911
    • 10127023
    • 10127026
    • Exp 10/31/2013. NeoCitran Extra Strength
  • Sugar Free Total 7 Symptom Relief
    • 10116036
    • Exp 6/30/2013 and 10122273
    • Exp 9/30/2013
Amount recalled
3,753,348 cartons

This recall covers 16 products

The agency filed one notice per product. You are reading one of them; the other 15 are below.

3 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 4, 2014 · Data as of Sep 19, 5:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.