CLASS II Drug recall · Reported 25 Sep 2013 · FDA Enforcement Report
Vicks NyQuil Cold and Flu Nighttime Relief recalled by Procter & Gamble
Procter & Gamble is recalling Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg, distributed nationwide in the US. The recall was initiated on 29 Aug 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-1056-2013
- FDA event ID
- 66157
- Recalling firm
- Procter & Gamble, Mason, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Aug 2013
- FDA classified
- 13 Sep 2013
- Reported
- 25 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Pain Medication
Timeline
| 29 Aug 2013 | Recall initiated by company | |
| 13 Sep 2013 | Classified by FDA | +15 days |
| 25 Sep 2013 | 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
Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the outer wrap does not correctly identify color additives, particularly FD&C Yellow No. 6 and FD&C Yellow 10.
Product as listed by the FDA
Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg, Dextromethorphan HBr 30mg, Doxylamine succinate 12.5mg), 12 fl oz (354 ml) bottles, Distributed by Procter & Gamble, Cincinnati, OH 45202, NDC 37000-807-12
Where it was distributed
Nationwide
Questions about this recall
Is Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg recalled?
Yes. Procter & Gamble recalled Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg on 29 Aug 2013. The recall is Class II and its status is Terminated. Recall number D-1056-2013.
Why was it recalled?
Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the outer wrap does not correctly identify color additives, particularly FD&C Yellow No. 6 and FD&C Yellow 10.
Which lots are affected?
Lot #s 31614334R1, 31814334R1, Exp 5/15; Twin packs were further packaged in display coded with following 4 Lot #s (display received by WalMart only): 3051A152HK, Exp 1/15, 3051A152HL, Exp. 1/15, 3051A152HM, Exp 1/15, 30746493F5, Exp 2/15
Where was it sold?
Nationwide
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Procter & Gamble
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg recalled | Procter & Gamble | Packaging Defects | Nationwide |
| Drug | CLASS II | Vicks NyQuil Cold & Flu, Nighttime Relief recalled by Procter & Gamble | Procter & Gamble | Other | Nationwide |