The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-751-2014·Announced 2014-01-29

Novartis Recalls Theraflu Powder Packets Due to Foreign Substance Presence

Novartis is recalling Theraflu and related cold medicine powder packets because they may contain foreign substances. The recall affects products distributed in the US, Canada, Mexico, and other countries.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 the presence of foreign substances in a drug product, which poses a risk of harm even without reported injuries.

Plain-English summary

Novartis Consumer Health is recalling specific lots of Theraflu powder packets, including Theraflu Sinus & Cold and Theraflu Cold & Sore Throat, as well as foreign-labeled products like NeoCitran Cold & Flu and Theraflu Exthegran. The recall is due to the potential presence of foreign substances in the products.

The affected products include 1,140,564 cartons 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 recall documentation, with expiration dates ranging from June 2013 to November 2013.

Consumers should stop using the recalled products and check their lot numbers against the list provided by the FDA or Novartis. If the product matches the recalled lots, consumers should return it to the place of purchase for a refund or contact Novartis Consumer Health for further instructions.

The recalled product

Product
Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, labeled as a) Theraflu Sinus & Cold (NDC…
Manufacturer
Novartis Consumer Health
Category
Drug — Cold and Flu Medicine
Hazard
Affected units
1,140,564

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) 10116014
  • Exp 6/30/2013
  • 10122246
  • Exp 7/31/2013
  • 10124322
  • Exp 9/30/2013
  • 10128122
  • Exp 11/30/2013
  • b) 10119852
  • 10122249
  • Exp 8/31/2013
  • 10124321
  • 10128118
  • 10128120
  • Exp 11/30/2013. NeoCitran Cold & Flu: 10115576
  • 10122243
  • Exp 8/31/2013 and 10124319
  • Theraflu Exthegran 10115579
  • 10115572
  • 10117549

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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