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

Recall Insight

This FDA Drug action (record #D-1352-2014) was formally reported on June 4, 2014, with the manufacturer initiating the action on April 25, 2014. It is classified under Low severity (Class III), with a current status of Terminated. Prestige Brands Holdings is listed as the recalling firm, operating out of Tarrytown, NY. Federal records indicate 12,269 cases/36 bottles units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution Distribution data in the federal record shows the product reached: Nationwide, and one consignee in Libya. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.