Mucinex Fast Max Cold — Class I drug recall D-1363-2015
Terminated recall by Reckitt Benckiser LLC, reported 2015-09-02, distributed nationwide. Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, ho
| Recall number | D-1363-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Reckitt Benckiser LLC, Parsippany, NJ, United States |
| Recall initiated | 2015-04-15 |
| Classified | 2015-08-25 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2018-03-09 |
| Distributed | Nationwide (US) |
| Quantity | 495,036 bottles |
| Reason classes | labeling |
| NDC | 63824-0015, 63824-0015-66, 63824-0015-69 |
| Lot numbers | MCF0048, MCF0051, MCF0052, MCF0053, MCF0054, MCF0055, MCF0056, MCF0057, MCF0058, MCF0059, MCF0060, MCF0061, MCF0062, MCF0063, MCF0064, MCF0065, MCF0066, MCF0067, MCF0068, MCF0069, MCF0070, MCF0071, MCF0072, MCF0073, MCF0074, MCF0075, MCF0076, MCF0077 |
Product
Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, , Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-015-66, UPC 63824-01565-1
Reason for recall
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.
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-1363-2015. 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.