FDA Drug recall D-744-2014
Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets
- FDA Drug
- Class III
- terminated
- Published 2014-01-22
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
| Agency | FDA Drug |
|---|---|
| Recall number | D-744-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-05-15 |
| Published | 2014-01-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Novartis Consumer Health |
| Distribution | US |
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_info | Lot# 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
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