Reported Jan 29, 2014 · Terminated

Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan…

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 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 byNovartis Consumer Health, Inc., Parsippany, NJ 07054-0622
Lot codes and dates
    • Lot #: a) 25777303
    • 25777304
    • Exp 5/31/2013
    • 25777501
    • 25777502
    • Exp 6/30/2013
    • 25777801
    • 25777802
    • Exp 7/31/2013
    • 25777803
    • 25981801
    • 25981802
    • Exp 8/31/2013
    • 25981803
    • 26088801
    • 26088802
    • Exp 9/30/2013
    • b) 25596201
    • 25596202
    • 25596203
    • 25596204
    • 25596205
    • 25596206
    • Exp 5/31/2013
    • 25596207
    • 25767001
    • 25767101
    • 25767102
    • 25767103
    • Exp 6/30/2013
    • 25767002
    • 25767104
    • 25767105
    • 25767106
    • 25767201
    • Exp 7/31/2013
    • 25767202
    • 25767203
    • 25767204
    • 25767205
    • 25767206
    • 25981602
    • 25981603
    • 25981604
    • 25981605
    • Exp 8/31/2013
    • 25981601
    • Exp 9/30/2013
Amount recalled
917,400 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.

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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, 5:03 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.