CLASS III Drug recall · Reported 4 Jun 2014 · FDA Enforcement Report
PediaCare Nighttime Multi-symptom Cold recalled
Prestige Brands Holdings is recalling PediaCare Nighttime Multi-symptom Cold, (diphenhydramine HCl 6.25 mg and phenylephrine, 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
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-1352-2014
- 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 NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed by Medtech Products, Inc., Tarrytown,NY ---- UPC 814832013544
Where it was distributed
Nationwide, and one consignee in Libya
Questions about this recall
Why was it recalled?
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Which lots are affected?
UPC 814832013544 Lots: Expiry Date 133196 01/2015 144273 02/2015 154090 09/2015 73242 05/2014 73243 05/2014 73244 05/2014 73824 06/2014 74207 06/2014 74303 06/2014 74460 06/2014 78805 09/2014 79265 10/2014 79266 10/2014 79573 09/2014 80456 06/2014 80457 07/2014 83746 01/2015
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | PediaCare Day & Night Value Pack Daytime Multi-symptom Cold recalled | Prestige Brands Holdings | Other | Nationwide |
More recalls from Prestige Brands Holdings
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clear Eyes Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper recalled | Prestige Brands Holdings | Sterility | Nationwide |
| Food | CLASS II | Little Remedies¿ Honey Cough recalled by Prestige Brands HoldingsLittle Remedies | Prestige Brands Holdings | Other Bacterial Contamination | Nationwide |
| Drug | CLASS III | PediaCare Day & Night Value Pack Daytime Multi-symptom Cold recalled | Prestige Brands Holdings | Other | Nationwide |