CLASS II Drug recall · Reported 29 Jan 2014 · FDA Enforcement Report
NeoCitran (acetaminophen 1000 mg recalled by Novartis Consumer Health
Novartis Consumer Health is recalling NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan, 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-758-2014
- 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
- Other Reasons
- 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.
Product as listed by the FDA
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 Strength Total Flu 7 Symptom Relief (UPC 0 58478 47365 9) and b) NeoCitran Extra Strength Sore Throat & Cough (UPC 0 58478 47365 9).
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 #: a) 10112236, Exp 4/30/2014 and 10122295, Exp 9/30/2014; b) 10093319, Exp 6/30/2013 and 10100417, Exp 9/30/2013.
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 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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|---|---|---|---|---|---|
| Food | CLASS II | Benefiber fiber supplement stick packs, sugar free and taste free recalledBenefiber | Novartis Consumer Health | Packaging Defects | Nationwide |
| Drug | CLASS II | Theraflu Flu & Sore Throat (acetaminophen 650 mg recalled | Novartis Consumer Health | Packaging Defects | Nationwide |
| Drug | CLASS II | Theraflu Exte (dextromethorphan hydrobromide 20 mg recalled | Novartis Consumer Health | Packaging Defects | Nationwide |
| Drug | CLASS II | Theraflu Nighttime Severe Cold & Cough recalled | Novartis Consumer Health | Packaging Defects | Nationwide |
| Drug | CLASS II | Theraflu Flu & Chest Congestion (acetaminophen 1000 mg recalled | Novartis Consumer Health | Other | Nationwide |