The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-844-2013·Announced 2013-08-14

Novartis Recalls Excedrin Migraine Pouches Due to Incomplete Seals

Novartis is recalling 10.6 million Excedrin Migraine pouches because the packaging may not be fully sealed, potentially compromising product integrity.

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 involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a packaging defect (incomplete seal) rather than a direct contamination or dosage error, fitting the Moderate severity criteria for low-risk contamination or packaging issues.

Plain-English summary

Novartis Consumer Health is recalling 10,624,000 pouches of Excedrin Migraine (Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg) and Excedrin Migrana. The recall affects 2-count tablets packaged in pouches distributed nationwide, in Puerto Rico, Brazil, and Panama.

The recall was initiated because the pouches may not have been fully sealed. This defect in the container could potentially affect the product's integrity. Specific lot numbers and expiration dates are listed in the official recall notice.

Consumers with these products should stop using them and contact Novartis Consumer Health for instructions on how to return the product or obtain a refund.

The recalled product

Product
Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203 702 Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin…
Manufacturer
Novartis Consumer Health
Category
Drug — Over-the-Counter Medication
Hazard
Affected units
10,624,000

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 (6)

  • Lot # a) 10116809
  • Exp 5/13 Foreign: Lot #s b) 10115644 Exp 5/13
  • 10118226 Exp 5/13
  • 10118227 Exp 6/13
  • 10118228 Exp 6/13
  • 10121956 Exp 8/13 and 10121957 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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