Drug recall: Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder…

Class II FDA enforcement event 65490. Recall start date: 18 Jun 2013. Status in the FDA record: Terminated. Termination date: 4 Nov 2014.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

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

Novartis Consumer Health started this drug recall on 18 Jun 2013. The firm address in the FDA record is in Lincoln, NE. FDA put the recall in Class II. FDA event 65490 has 16 product records. The first FDA enforcement report date is 29 Jan 2014. The record gives the status Terminated, with the termination date 4 Nov 2014.

FDA enforcement report The 16 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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

Recalling firm

Novartis Consumer Health, Lincoln, NE.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

16 product records in the event.

FDA event 65490: product records
Recall number	Product	Quantity	Class	Status	Report date
D-748-2014	Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Apple Cinnamon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7916-06, UPC 3 0043-0479-16 3. Also packaged…	1,614,564 cartons	Class II	Terminated	29 Jan 2014
D-749-2014	Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Berry Infused with Menthol & Green Tea flavors, 6-count packets per carton, , Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6257-06,…	1,871,122 cartons	Class II	Terminated	29 Jan 2014
D-750-2014	Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol & Green Tea flavors and Nighttime formula (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, and phenylephrine…	917,400 cartons	Class II	Terminated	29 Jan 2014
D-751-2014	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)…	1,140,564 cartons	Class II	Terminated	29 Jan 2014
D-752-2014	Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Green Tea & Honey Lemon flavors, packaged in a) 6-count packets per carton (NDC 0067-6426-06, UPC 3 0067-6426-06 8) and b) 1-count packet per card (NDC 0067-6426-01, UPC 3…	1,202,960 cartons and cards	Class II	Terminated	29 Jan 2014
D-753-2014	Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6427-06, UPC 3 0067-6427-06 5. Also…	868,104 cartons	Class II	Terminated	29 Jan 2014
D-754-2014	Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6318-06, UPC 3…	292,320 cartons	Class II	Terminated	29 Jan 2014
D-755-2014	Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-0483-06, UPC 3 0043-0483-06 1.	398,208 cartons	Class II	Terminated	29 Jan 2014
D-756-2014	Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon Infused with Chamomille & White Tea flavors, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC…	3,753,348 cartons	Class II	Terminated	29 Jan 2014
D-757-2014	NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 20mg, chlorpheniramine maleate 4 mg, ascorbic acid 5 mg) powder packets, Soothing Lemon flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada Inc., Mississauga, ON, labeled as a)…		Class II	Terminated	29 Jan 2014
D-758-2014	NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg) powder packets, Natural Source Cherry flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, labeled as a) NeoCitran Ultra…		Class II	Terminated	29 Jan 2014
D-759-2014	NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga , ON, UPC 0 58478 05103 1. Also packaged under foreign…		Class II	Terminated	29 Jan 2014
D-760-2014	NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05503 9.		Class II	Terminated	29 Jan 2014
D-761-2014	NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05703 3. Also packaged under foreign label: Theraflu…		Class II	Terminated	29 Jan 2014
D-762-2014	Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812881) and b) 10-count packets per carton (UPC 7 501124 814595), Distributed by Novartis Farmaceutica, S.A., DE…		Class II	Terminated	29 Jan 2014
D-763-2014	Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berries flavor, 10-count packets per box, UPC 4 607045 191760. (Russian product and Former Soviet Union product)		Class II	Terminated	29 Jan 2014

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2013: 370
Share of these events in Class II: 56%
Product records in this event: 16Median of the firm: 5
Events of the firm on the register: 11

Other events of the firm

Other FDA enforcement events of Novartis Consumer Health
Initiated	Product (first record)	Type	Class	Records
18 Dec 2013	Benefiber fiber supplement stick packs, sugar free and taste free, packaged in the following configurations: (1) Benefib	Food	Class II	1
3 Sep 2013	Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufactured by Novartis Consumer Health, Inc, Linc	Drug	Class III	1
6 Aug 2013	Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorte	Drug	Class III	9
6 Aug 2013	Benefiber, Fiber plus Calcium Supplement, Wild Berry Chewables 90ct, sugar free, chewable tablets bottle. Novartis Consu	Food	Class III	5
6 Jun 2013	Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b)	Drug	Class II	4
15 May 2013	Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR	Drug	Class III	7
7 May 2013	Benefiber Fiber Supplement, Orange Natural Flavor, Non-Thickening Powder, Sugar Free, packaged in 5.7-oz. (35 servings)	Food	Class II	6
19 Apr 2013	Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ	Drug	Class III	1
7 Mar 2013	Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label i	Drug	Class III	5
19 Feb 2013	Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ	Drug	Class III	5

Novartis Consumer Health: all 11 events

Official channels

FDA enforcement report D-748-2014The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 65490. https://recallregister.com/fda/ii/65490/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
What quantity of product is in FDA event 65490?: The event has 16 product records. The first record gives this quantity: 1,614,564 cartons
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2013 have the same class?: 56% of the 370 drug events that started in 2013 are in Class II.