CLASS II Drug recall · Reported 29 Jan 2014 · FDA Enforcement Report
Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg recalled
Novartis Consumer Health is recalling Theraflu Multi-Symptom Severe Cold (acetaminophen 500 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-752-2014
- FDA event ID
- 65490
- Recalling firm
- Novartis Consumer Health, Lincoln, NE
- Brand
- Theraflu
- Manufacturer
- Haleon US Holdings LLC
- 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 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 0067-6426-01 3), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.
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) 10116016, Exp 6/30/2013; 10118931, Exp 7/31/2013; 10121950, Exp 8/31/2013; 10122314, 10122316, 10124226, Exp 9/30/2013; 10124377, 10124379, 10125916, 10128112, 10128114, Exp 10/31/2013; b) 25872801, Exp 7/31/2013
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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Other Acetaminophen recalls
All 63| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each recalledTylenol Extra Strength | Kenvue Brands | Other | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalledAcetaminophen, Ibuprofen | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalledSevere Cold And Flu Plus Congestion | LNK International | Manufacturing (CGMP) Deviations | Nationwide |