RecallRadar

FDA Drug recall D-749-2014

Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder…

On 2014-01-29 the FDA classified a Class II recall of Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder… by Novartis Consumer Health, citing presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-749-2014
ClassificationClass II
Statusterminated
Initiated2013-06-18
Published2014-01-29
Last updated2026-09-13 11:51 UTC
CompanyNovartis Consumer Health
DistributionUS

Product

Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Berry Infused with Menthol & Green Tea flavors, 6-count packets per carton, , Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6257-06, UPC 3 0043-6257-06 2. Also packaged under foreign label: NeoCitran Extra Strength Daytime Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, dextromethorphan hydrobromide 20 mg) powder packets, Invigorating Berry with Green Tea flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada Inc., Mississauga, ON, UPC 0 58478 10366 2.

Reason

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Identifiers

upc300436257062
upc058478103662
code_info
Lot #: 10115840, 10115888, Exp 5/31/2013; 10118946, 10118948, 10119864, 10119867, Exp 7/31/2013; 10122271, 10122297, 1…Lot #: 10115840, 10115888, Exp 5/31/2013; 10118946, 10118948, 10119864, 10119867, Exp 7/31/2013; 10122271, 10122297, 10124374, Exp 8/31/2013; 10122300, Exp 9/30/2013; 10124493, 10125910, 10128097, 10128099, 10128101, Exp 10/31/2013. NeoCitran Extra Strength Total 7 symptom relief: 10115129, Exp 5/31/2013; 10124152, Exp 8/31/2013; and 10124488, Exp 10/31/2013.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-749-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.