The Recall Desk
ModerateFDA (Drugs)·D-827-2013·Announced 2013-08-07

Procter & Gamble Recalls DayQuil and NyQuil Sinex Liquicaps Due to Packaging Defects

Procter & Gamble is recalling 35,568 cartons of DayQuil and NyQuil Sinex liquicaps nationwide due to packaging defects that may cause missing or misplaced capsules.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a packaging defect (mispackaging) that could lead to dosing errors, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Procter & Gamble Co is voluntarily recalling 35,568 cartons of DayQuil Sinex DayTime Sinus Relief and NyQuil Sinex NightTime Sinus Relief Combopacks. The affected products are 48-count liquicaps cartons containing 32 DayQuil and 16 NyQuil capsules, distributed nationwide. The specific lot number is 3051171961 with an expiration date of 09/14.

The recall was initiated due to a unit dose mispackaging defect. This packaging issue could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed liquicaps within the blisters. The agency has classified this recall as Class II.

Consumers who have purchased these specific cartons should stop using the product and contact Procter & Gamble for a refund or further instructions. The products were made in Canada and distributed by Procter & Gamble in Cincinnati, OH.

The recalled product

Product
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
Affected units
35,568

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot # 3051171961
  • Exp 09/14
  • Brand Code 84855363

Distribution

Distributed nationwide across the United States.

Same manufacturer · Procter & Gamble Co

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