The Recall Desk
ModerateFDA (Drugs)·D-749-2014·Announced 2014-01-29

Novartis Recalls Theraflu Cold and Cough Powder Packets

Novartis is recalling Theraflu Daytime Severe Cold & Cough powder packets and NeoCitran products due to the potential presence of foreign substances.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential foreign substances without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Novartis Consumer Health is recalling specific lots of Theraflu Daytime Severe Cold & Cough powder packets and NeoCitran Extra Strength Daytime Total 7 Symptom Relief powder packets. The recall involves 1,871,122 cartons distributed nationwide and in Mexico, Russia, Korea, Panama, China, and Canada.

The products are being recalled because they may contain foreign substances. The affected Theraflu products include Berry Infused with Menthol & Green Tea flavors, while the NeoCitran products include Invigorating Berry with Green Tea flavor. Specific lot numbers and expiration dates are listed in the recall notice.

Consumers should stop using the recalled products and check their lot numbers against the list provided by the FDA. Those with questions can contact Novartis Consumer Health for further information.

The recalled product

Product
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., Parsip
Manufacturer
Novartis Consumer Health
Category
Drug — Cold and Flu
Hazard
Affected units
1,871,122

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 #: 10115840
  • 10115888
  • Exp 5/31/2013
  • 10118946
  • 10118948
  • 10119864
  • 10119867
  • Exp 7/31/2013
  • 10122271
  • 10122297
  • 10124374
  • Exp 8/31/2013
  • 10122300
  • Exp 9/30/2013
  • 10124493
  • 10125910
  • 10128097
  • 10128099
  • 10128101
  • Exp 10/31/2013. NeoCitran Extra Strength Total 7 symptom relief: 10115129

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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