The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-843-2013·Announced 2013-08-14

Novartis Recalls Excedrin Extra Strength Due to Unsealed Pouches

Novartis is recalling Excedrin Extra Strength tablets in pouches that may not be fully sealed. The recall covers products distributed in the US, Puerto Rico, Brazil, and Panama.

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 2/5 (Moderate).

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 may cause temporary or medically reversible health consequences. The hazard is a packaging defect (unsealed pouches) rather than a direct chemical or biological contamination, and no illnesses or injuries are reported in the source text.

Plain-English summary

Novartis Consumer Health is recalling specific lots of Excedrin Extra Strength tablets (Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg). The recall involves 2-count tablets in pouches and boxes of 50/2-count packages, as well as foreign packaging labeled Parsel Forte and Cibalenaa. The affected products are distributed by Novartis Consumer Health, Inc., in Parsippany, NJ.

The recall was initiated because the products are packaged in pouches which may not have been fully sealed. This defect could potentially affect the integrity of the packaging. The recall covers approximately 4.17 million pouches, 101,300 boxes, and 38,235 foreign packaging units.

The affected products were distributed nationwide in the United States, as well as in Puerto Rico, Brazil, and Panama. Consumers should check their lot numbers and expiration dates against the list provided in the official recall notice. If the product matches the recalled lots, consumers should stop using it and contact Novartis Consumer Health for instructions on return or disposal.

The recalled product

Product
Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2030 02 Foreign packaging: c) Parsel Forte and d)…
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 (11)

  • Lot #s a) 10120190
  • Exp 6/13 and 10121628
  • Exp 7/13
  • Lot #s b) 10115658
  • Exp 5/13
  • 10116807
  • 10121630
  • Exp 7/13 and 10125253
  • Exp 9/13 Foreign Lot #s c) 10120192
  • d)10120272
  • 10121528 Exp 7/13 and 10121958 Exp 8/13

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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