CLASS II Drug recall · Reported 7 Aug 2013 · FDA Enforcement Report
DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg recalled
Procter & Gamble is recalling DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg), distributed nationwide in the US. The recall was initiated on 3 Jul 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-827-2013
- FDA event ID
- 65650
- Recalling firm
- Procter & Gamble, Mason, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jul 2013
- FDA classified
- 26 Jul 2013
- Reported
- 7 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 3 Jul 2013 | Recall initiated by company | |
| 26 Jul 2013 | Classified by FDA | +23 days |
| 7 Aug 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
Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed liquicaps within the blisters.
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
DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) liquicaps and NyQuil Sinex NightTime Sinus Relief (acetaminophen 325 mg, doxylamine succinate 6.25 mg, and phenylephrine HCl 5 mg) liquicaps Combopack, each 48-count liquicaps per carton contains 32 DayQuil Sinex DayTime Liquicaps and 16 NyQuil Sinex NightTime Liquicaps per carton, Made In Canada, Dist. by Procter & Gamble, Cincinnati, OH 45202, UPC 3 23900 01454 1.
Where it was distributed
Nationwide
Questions about this recall
Is DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) recalled?
Yes. Procter & Gamble recalled DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) on 3 Jul 2013. The recall is Class II and its status is Terminated. Recall number D-827-2013.
Why was it recalled?
Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed liquicaps within the blisters.
Which lots are affected?
Lot # 3051171961, Exp 09/14; Brand Code 84855363
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 | Vicks NyQuil Cold and Flu Nighttime Relief recalled by Procter & Gamble | Procter & Gamble | Labeling Errors | Nationwide |
| Drug | CLASS II | Vicks NyQuil Cold & Flu, Nighttime Relief recalled by Procter & Gamble | Procter & Gamble | Other | Nationwide |