FDA Drug recall D-1365-2015
Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Phenylephrine HCl Nasa…
- FDA Drug
- Class I
- terminated
- Published 2015-09-02
On 2015-09-02 the FDA classified a Class I recall of Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Phenylephrine HCl Nasa… 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-1365-2015 |
| 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 Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, 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 63824-016-66, UPC 63824-01665-8
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 | 63824016658 |
|---|---|
| code_info | Lot #: Exp: MCS0019 7/31/2016 MCS0020 7/31/2016 MCS0021 7/31/2016 MCS0022 8/31/2016 MCS0023 8/31/2016 M…Lot #: Exp: MCS0019 7/31/2016 MCS0020 7/31/2016 MCS0021 7/31/2016 MCS0022 8/31/2016 MCS0023 8/31/2016 MCS0024 9/30/2016 MCS0025 9/30/2016 MCS0026 9/30/2016 MCS0027 11/30/2016 MCS0028 10/31/2016 MCS0029 10/31/2016 MCS0030 12/31/2016 MCS0031 12/31/2016 MCS0032 12/31/2016 MCS0033 12/31/2016 |
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-1365-2015%22
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