CLASS III Drug recall · Reported 4 Jun 2014 · FDA Enforcement Report

PediaCare Day & Night Value Pack Daytime Multi-symptom Cold recalled

Prestige Brands Holdings is recalling PediaCare Day & Night Value Pack Daytime Multi-symptom Cold (dextromethorphan HBr 5 mg, distributed nationwide in the US. The recall was initiated on 25 Apr 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesUPC 814832013523 Lots: Expiry Date 148342 07/2015 148347 08/2015 149297 08/2015 149382 07/2015 149516 08/2015 152298 08/2015 73143 04/2014 73719 05/2014 74195 06/2014 74805 06/2014 75180 06/2014 79186 09/2014 79323 09/2014

Quantity recalled17,479 cases/12 dual packs

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-1353-2014
FDA event ID: 68130
Recalling firm: Prestige Brands Holdings, Tarrytown, NY
Classification: Class III
Status: Terminated
Recall initiated: 25 Apr 2014
FDA classified: 28 May 2014
Reported: 4 Jun 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Allergy Medication

Timeline

25 Apr 2014	Recall initiated by company
28 May 2014	Classified by FDA	+33 days
4 Jun 2014	Published in enforcement report	+7 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 Precipitate; small amounts of diphenhydramine precipitated out of solution

Product as listed by the FDA

PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 mg) and NIGHTTIME MULTI-SYMPTOM Cold (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL oz (118 mL) bottles, one each of DAYTIME MULTI-SYMPTOM Cold, Distributed by Medtech Products, Inc., Tarrytown, NY --- UPC 814832013523

Where it was distributed

Nationwide, and one consignee in Libya

Nationwide

Questions about this recall

Why was it recalled?

Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution

Which lots are affected?

UPC 814832013523 Lots: Expiry Date 148342 07/2015 148347 08/2015 149297 08/2015 149382 07/2015 149516 08/2015 152298 08/2015 73143 04/2014 73719 05/2014 74195 06/2014 74805 06/2014 75180 06/2014 79186 09/2014 79323 09/2014

Where was it sold?

Nationwide, and one consignee in Libya

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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

1 other product · FDA event 68130

This product is part of a recall event; the main page for the event is PediaCare Nighttime Multi-symptom Cold recalled.

Reported	Class	Recall	Company	Reason	Where
4 Jun 2014	CLASS III	PediaCare Nighttime Multi-symptom Cold recalled	Prestige Brands Holdings	Other	Nationwide

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