FDA Drug recall D-1517-2016
Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60
- FDA Drug
- Class III
- terminated
- Published 2016-09-28
On 2016-09-28 the FDA classified a Class III recall of Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60 by Reckitt Benckiser, citing labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime a….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1517-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-08-03 |
| Published | 2016-09-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Reckitt Benckiser |
| Distribution | FL, MA, NJ |
Product
Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60
Reason
Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.
Identifiers
| upc | 363824951737 |
|---|---|
| code_info | WO00809739, 9/2017 |
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-1517-2016%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.