The Recall Desk
HighFDA (Drugs)·D-756-2014·Announced 2014-01-29

Theraflu Nighttime Severe Cold & Cough Powder Packets Recalled for Foreign Substances

Novartis Consumer Health is recalling Theraflu Nighttime Severe Cold & Cough powder packets because they may contain foreign substances.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential foreign substances in a drug product where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Novartis Consumer Health is voluntarily recalling specific lots of Theraflu Nighttime Severe Cold & Cough powder packets and NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief pouches. The recall is due to the potential presence of foreign substances in the products.

The affected products include Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets in Honey Lemon Infused with Chamomille & White Tea flavors, and NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief pouches. The recall covers 3,753,348 cartons distributed nationwide and in Mexico, Russia, Korea, Panama, China, and Canada.

Consumers should check their lot numbers and expiration dates against the list provided in the official recall notice. If the product matches the recalled lots, consumers should stop using it and contact Novartis Consumer Health for a refund or replacement.

The recalled product

Product
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
Manufacturer
Novartis Consumer Health
Category
Drug — Cold & Flu
Hazard
Affected units
3,753,348

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 16 recalled by Novartis Consumer Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 16 products in this recall →

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