The Recall Desk
ModerateFDA (Drugs)·D-750-2014·Announced 2014-01-29

Novartis Recalls Theraflu Severe Cold & Cough Powder Packets for Foreign Substances

Novartis Consumer Health is recalling Theraflu Severe Cold & Cough powder packets because they may contain foreign substances. The recall covers 917,400 cartons distributed in the US and internationally.

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, which typically involves a reasonable probability of temporary or medically reversible health consequences. The hazard is the presence of foreign substances, which is a low-risk contamination issue without reported illnesses or injuries in the source text.

Plain-English summary

Novartis Consumer Health is voluntarily recalling Theraflu Severe Cold & Cough powder packets containing Daytime and Nighttime formulas. The recall is being conducted because the products may contain foreign substances. The affected products include Berry Infused with Menthol & Green Tea flavors and Honey Lemon Infused with Chamomile & White Tea flavors, packaged in 24-count and 12-count cartons.

The recall involves 917,400 cartons. These products were distributed nationwide in the United States, as well as in Mexico, Russia, Korea, Panama, China, and Canada. Specific lot numbers and expiration dates are listed in the official recall notice.

Consumers should check their cartons for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled items, consumers should stop using it and contact Novartis Consumer Health for a refund or further instructions.

The recalled product

Product
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 h
Manufacturer
Novartis Consumer Health
Category
Drug — OTC Cold & Flu
Hazard
Affected units
917,400

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 #: 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

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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