Mucinex Sinus-Max Day Night — Class III drug recall D-1517-2016
Terminated recall by Reckitt Benckiser LLC, reported 2016-09-28, distributed in FL, MA, NJ. Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg ins
| Recall number | D-1517-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Reckitt Benckiser LLC, Parsippany, NJ, United States |
| Recall initiated | 2016-08-03 |
| Classified | 2016-09-22 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2018-03-05 |
| Distributed | FL, MA, NJ |
| Quantity | 738 boxes |
| Reason classes | labeling, potency |
| UPC / GTIN / UDI-DI | 00363824951737 |
| NDC | 63824-0207-60 |
Product
Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1517-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.