Food, drugs, devices › Prestige Brands Holdings
Drug recall: PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 m
FDA enforcement event 68130 is a drug recall by Prestige Brands Holdings of Tarrytown, NY, initiated 25 Apr 2014 and classified Class III, with 2 product records.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 27% of the 313 drug enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 15 Sep 2015. Initiation: voluntary: firm initiated. Prestige Brands Holdings has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Prestige Brands Holdings, Tarrytown, NY.
Reason for recall
"Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution"
Distribution
"Nationwide, and one consignee in Libya"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1352-2014 | 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 | 12,269 cases/36 bottles | Class III | Terminated | 4 Jun 2014 |
| D-1353-2014 | 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,… | 17,479 cases/12 dual packs | Class III | Terminated | 4 Jun 2014 |
Context
Other enforcement events for Prestige Brands Holdings
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Jul 2026 | CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarr | Drug | Class II | 1 |
| 18 Jun 2025 | Little Remedies¿ Honey Cough 4 FL OZ (118 mL) | Food | Class II | 1 |
All 3 events for Prestige Brands Holdings
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide, and one consignee in Libya"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Sep 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.