Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6318-06, UPC 3 0043-6318-06 0.

Recall Insight

This FDA Drug action (record #D-754-2014) was formally reported on January 29, 2014, with the manufacturer initiating the action on June 18, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Novartis Consumer Health is listed as the recalling firm, operating out of Lincoln, NE. Federal records indicate 292,320 cartons units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Distribution data in the federal record shows the product reached: Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.. 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, of which 5 were also issued by FDA Drug. 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.