Drug recall: Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan…

Class III FDA enforcement event 65181. Recall start date: 15 May 2013. Status in the FDA record: Terminated. Termination date: 4 Nov 2014.

Reason for recall, in the words of FDA

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Novartis Consumer Health started this drug recall on 15 May 2013. The firm address in the FDA record is in Lincoln, NE. FDA put the recall in Class III. FDA event 65181 has 7 product records. The first FDA enforcement report date is 22 Jan 2014. The record gives the status Terminated, with the termination date 4 Nov 2014.

FDA enforcement report The 7 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.

Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.

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

7 product records in the event.

FDA event 65181: product records
Recall number	Product	Quantity	Class	Status	Report date
D-738-2014	Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: Novartis Consumer Health, Inc.,…	104,328/32-caplet packages	Class III	Terminated	22 Jan 2014
D-739-2014	Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula *includes antihistamine, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2081-24.	32,256/24-caplet packages	Class III	Terminated	22 Jan 2014
D-740-2014	Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC…	38,856/24-caplet package	Class III	Terminated	22 Jan 2014
D-741-2014	Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Novartis, distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2081-24	167,712/24-caplet packages	Class III	Terminated	22 Jan 2014
D-742-2014	Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-6438-24), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.	98,024/8-caplet packages and 557,548/24-caplet packages	Class III	Terminated	22 Jan 2014
D-743-2014	Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 10mg , Phenylephrine HCL 5mg, a) 8 coated caplets (NDC 0067-6437-08) b) 24 coated caplets (NDC 0067-6438-24). Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ.…	3,768/8-caplet packages and 300,580/24-caplet packages	Class III	Terminated	22 Jan 2014
D-744-2014	Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.	2,978,000/2-caplet packages	Class III	Terminated	22 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 III: The lowest of the three FDA recall classes.

The event in context

Drug events that started in 2013: 370
Share of these events in Class III: 26%
Product records in this event: 7Median 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
18 Jun 2013	Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder p	Drug	Class II	16
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
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-738-2014The 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 65181. https://recallregister.com/fda/iii/65181/. 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: Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
What quantity of product is in FDA event 65181?: The event has 7 product records. The first record gives this quantity: 104,328/32-caplet packages
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2013 have the same class?: 26% of the 370 drug events that started in 2013 are in Class III.