CLASS II Drug recall · Reported 14 Aug 2013 · FDA Enforcement Report
Excedrin Migraine (Acetaminophen 250 mg, Aspirin recalled
Novartis Consumer Health is recalling Excedrin Migraine (Acetaminophen 250 mg, Aspirin (Nsaid) 250 mg and Caffeine 65 mg), a), distributed nationwide in the US. The recall was initiated on 6 Jun 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-844-2013
- FDA event ID
- 65422
- Recalling firm
- Novartis Consumer Health, Lincoln, NE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jun 2013
- FDA classified
- 6 Aug 2013
- Reported
- 14 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 6 Jun 2013 | Recall initiated by company | |
| 6 Aug 2013 | Classified by FDA | +61 days |
| 14 Aug 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container: products are packaged in pouches which may not have been fully sealed
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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 250 mg and 65 mg Caffeine) 2-ct pouches. The foreign packaging do not have NDC numbers
Where it was distributed
Nationwide, Puerto Rico, Brazil and Panama
Questions about this recall
Why was it recalled?
Defective container: products are packaged in pouches which may not have been fully sealed
Which lots are affected?
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
Where was it sold?
Nationwide, Puerto Rico, Brazil and Panama
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 65422| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg) recalled | Novartis Consumer Health | Packaging Defects | Nationwide | |
| CLASS II | No Doz, Max Strength (200 mg caffeine) caplets recalled | Novartis Consumer Health | Packaging Defects | Nationwide | |
| CLASS II | Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin recalled | Novartis Consumer Health | Packaging Defects | Nationwide |
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