CLASS II Drug recall · Reported 29 Jan 2014 · FDA Enforcement Report

Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg recalled

Novartis Consumer Health is recalling Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10, distributed nationwide in the US. The recall was initiated on 18 Jun 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: a) 10116014, Exp 6/30/2013; 10122246, Exp 7/31/2013; 10124322, Exp 9/30/2013; 10128122, Exp 11/30/2013; b) 10119852, Exp 7/31/2013; 10122249, Exp 8/31/2013; 10124321, Exp 9/30/2013; 10128118, Exp 11/30/2013; 10128120, Exp 11/30/2013. NeoCitran Cold & Flu: 10115576, Exp 6/30/2013; 10122243, Exp 8/31/2013 and 10124319, Exp 9/30/2013; Theraflu Exthegran 10115579, 10115572, Exp 6/30/2013; 10117549, Exp 8/30/2013.

Quantity recalled1,140,564 cartons

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-751-2014
FDA event ID: 65490
Recalling firm: Novartis Consumer Health, Lincoln, NE
Classification: Class II
Status: Terminated
Recall initiated: 18 Jun 2013
FDA classified: 17 Jan 2014
Reported: 29 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Pain Medication

Timeline

18 Jun 2013	Recall initiated by company
17 Jan 2014	Classified by FDA	+213 days
29 Jan 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

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

Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, labeled as a) Theraflu Sinus & Cold (NDC 0067-6319-06, UPC 3 0043-6319-06 7) and b) Theraflu Cold & Sore Throat (NDC 0067-6716-06, UPC 3 0043-0467-16 0). Also packaged under foreign labels: NeoCitran Cold & Flu powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05009 6; and Theraflu Exthegran powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812904) and b) 10-count packets per carton (UPC 7 501124 814588), Distributed by Novartis Farmaceutica S.A. De C.V., Mexico

Where it was distributed

Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.

Nationwide

Questions about this recall

Is Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 recalled?

Yes. Novartis Consumer Health recalled Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 on 18 Jun 2013. The recall is Class II and its status is Terminated. Recall number D-751-2014.

Why was it recalled?

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Which lots are affected?

Lot #: a) 10116014, Exp 6/30/2013; 10122246, Exp 7/31/2013; 10124322, Exp 9/30/2013; 10128122, Exp 11/30/2013; b) 10119852, Exp 7/31/2013; 10122249, Exp 8/31/2013; 10124321, Exp 9/30/2013; 10128118, Exp 11/30/2013; 10128120, Exp 11/30/2013. NeoCitran Cold & Flu: 10115576, Exp 6/30/2013; 10122243, Exp 8/31/2013 and 10124319, Exp 9/30/2013; Theraflu Exthegran 10115579, 10115572, Exp 6/30/2013; 10117549, Exp 8/30/2013.

Where was it sold?

Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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