FDA Drug recall D-1368-2015
Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl o…
- FDA Drug
- Class I
- terminated
- Published 2015-09-02
On 2015-09-02 the FDA classified a Class I recall of Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl o… by Reckitt Benckiser, citing labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is mis….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1368-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-04-15 |
| Published | 2015-09-02 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Reckitt Benckiser |
| Distribution | US |
Product
Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl oz (360 mL), For Ages 12+, Dist. by Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-528-22-01, NDC 63824-528-22-00, UPC 63824-52822-9
Reason
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Identifiers
| upc | 63824528229 |
|---|---|
| code_info | Lot #: Exp: WO00707825 5/31/2016 WO00713226 7/31/2016 WO00715310 6/30…Lot #: Exp: WO00707825 5/31/2016 WO00713226 7/31/2016 WO00715310 6/30/2016 WO00715505 7/31/2016 WO00721174 9/30/2016 WO00721177 10/31/2016 WO00726860 10/31/2016 WO00726862 6/30/2016 WO00726952 8/31/2016 WO00728861 6/30/2016 WO00728878 7/31/2016 WO00728879 9/30/2016 |
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-1368-2015%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.