The Recall Desk
ModerateFDA (Drugs)·D-757-2014·Announced 2014-01-29

Novartis Recalls NeoCitran Extra Strength Powder Packets Due to Foreign Substances

Novartis Consumer Health is recalling NeoCitran Extra Strength powder packets because they may contain foreign substances. The products were distributed nationwide 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 indicates a situation where use of the product could cause temporary or medically reversible health consequences. The presence of foreign substances is a potential hazard, but no specific injuries or illnesses are reported in the source text, placing it in the moderate range rather than high or severe.

Plain-English summary

Novartis Consumer Health is voluntarily recalling specific lots of NeoCitran Extra Strength powder packets, Soothing Lemon flavor. The recall is being conducted because the products may contain foreign substances.

The affected products are labeled as either NeoCitran Extra Strength Nighttime Total 7 Symptom Relief or NeoCitran Extra Strength Cough, Cold & Flu. The recall covers 10-single dose pouches per carton. Specific lot numbers and expiration dates are listed in the official recall notice.

The products were distributed nationwide in the United States, as well as in Mexico, Russia, Korea, Panama, China, and Canada. Consumers should stop using the recalled products and check their lot numbers against the official list to determine if they are affected.

The recalled product

Product
NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 20mg, chlorpheniramine maleate 4 mg, ascorbic acid 5 mg) powder packets, Soothing Lemon flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada In
Manufacturer
Novartis Consumer Health
Category
Drug — Over-the-Counter Medication
Hazard

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) 10094895
  • Exp 7/31/2013
  • 10098586
  • Exp 9/30/2013
  • 10104820
  • Exp 12/31/2013
  • 10109982
  • Exp 2/28/2014
  • 10110876
  • Exp 3/31/2014
  • 10114393
  • Exp 5/31/2014
  • 10119851
  • Exp 7/31/2014
  • 10122313
  • Exp 9/30/2014
  • b) 10097661
  • Exp 8/31/2013
  • 10099912
  • 10105539

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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