CLASS II Drug recall · Reported 14 Aug 2013 · FDA Enforcement Report

Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin recalled

Novartis Consumer Health is recalling Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (Nsaid) 250 mg and Caffeine 65 mg), 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

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

Quantity recalleda) 4,178,000 pouches; b) 101,300 boxes and c) & d) 38,235 pouches and boxes (combined)

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-843-2013
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 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) Cibalenaa (250 mg Acetaminophen, 250 mg Aspirin, 65 mg Caffeine), boxes of 48/4-ct pouches Foreign packaging do not have NDC numbers.

Where it was distributed

Nationwide, Puerto Rico, Brazil and Panama

Nationwide Puerto Rico

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

This product is part of a recall event; the main page for the event is Excedrin Migraine (Acetaminophen 250 mg, Aspirin recalled.

Reported	Class	Recall	Company	Reason	Where
14 Aug 2013	CLASS II	Excedrin Migraine (Acetaminophen 250 mg, Aspirin recalled	Novartis Consumer Health	Packaging Defects	Nationwide
14 Aug 2013	CLASS II	Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg) recalled	Novartis Consumer Health	Packaging Defects	Nationwide
14 Aug 2013	CLASS II	No Doz, Max Strength (200 mg caffeine) caplets recalled	Novartis Consumer Health	Packaging Defects	Nationwide

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