The Recall Desk
ModerateFDA (Drugs)·D-752-2014·Announced 2014-01-29

Theraflu Cold Powder Recalled for Potential Foreign Substances

Novartis Consumer Health is recalling Theraflu Multi-Symptom Severe Cold powder packets because they may contain 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, which typically indicates a situation where use of the product could cause temporary or medically reversible adverse health consequences. The hazard is the presence of foreign substances, which is a moderate risk without specific reports of severe injury or death.

Plain-English summary

Novartis Consumer Health is recalling Theraflu Multi-Symptom Severe Cold powder packets in Green Tea & Honey Lemon flavors. The affected products contain acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride and are packaged in 6-count cartons and 1-count cards.

The recall was initiated because the products may contain foreign substances. The affected units were distributed nationwide and in Mexico, Russia, Korea, Panama, China, and Canada.

Consumers should stop using the recalled products and contact Novartis Consumer Health for further instructions. The recall covers approximately 1.2 million cartons and cards across multiple lot numbers and expiration dates.

The recalled product

Product
THERAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL)
Brand
THERAFLU
Manufacturer
Novartis Consumer Health
Category
Drug — OTC Cold Medicine
Hazard
Affected units
1,202,960

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 (17)

  • Lot #: a) 10116016
  • Exp 6/30/2013
  • 10118931
  • Exp 7/31/2013
  • 10121950
  • Exp 8/31/2013
  • 10122314
  • 10122316
  • 10124226
  • Exp 9/30/2013
  • 10124377
  • 10124379
  • 10125916
  • 10128112
  • 10128114
  • Exp 10/31/2013
  • b) 25872801

UPCs (2)

  • 300676426068
  • 300676426013

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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Same hazard · foreign substance

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