RecallRadar

FDA Drug recall D-744-2014

Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets

On 2014-01-22 the FDA classified a Class III recall of Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets by Novartis Consumer Health, citing failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-744-2014
ClassificationClass III
Statusterminated
Initiated2013-05-15
Published2014-01-22
Last updated2026-09-13 11:51 UTC
CompanyNovartis Consumer Health
DistributionUS

Product

Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.

Reason

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

Identifiers

code_infoLot# 10118234 Exp 05/13 Lot# 10120254 Exp 05/13 Lot# 10123513 Exp 08/13 Lot#10125262 Exp 09/13

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-744-2014%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.