CLASS II Drug recall · Reported 29 Jan 2014 · FDA Enforcement Report
Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg recalled
Novartis Consumer Health is recalling Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide, 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
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-749-2014
- 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 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, UPC 3 0043-6257-06 2. Also packaged under foreign label: NeoCitran Extra Strength Daytime Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, dextromethorphan hydrobromide 20 mg) powder packets, Invigorating Berry with Green Tea flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada Inc., Mississauga, ON, UPC 0 58478 10366 2.
Where it was distributed
Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Which lots are affected?
Lot #: 10115840, 10115888, Exp 5/31/2013; 10118946, 10118948, 10119864, 10119867, Exp 7/31/2013; 10122271, 10122297, 10124374, Exp 8/31/2013; 10122300, Exp 9/30/2013; 10124493, 10125910, 10128097, 10128099, 10128101, Exp 10/31/2013. NeoCitran Extra Strength Total 7 symptom relief: 10115129, Exp 5/31/2013; 10124152, Exp 8/31/2013; and 10124488, Exp 10/31/2013.
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 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
15 other products · FDA event 65490This product is part of a recall event; the main page for the event is NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg recalled.
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