CLASS III Drug recall · Reported 29 Apr 2015 · FDA Enforcement Report
Mucinex DM (guaifenesin 600mg recalled by Reckitt Benckiser
Reckitt Benckiser is recalling Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer, distributed nationwide in the US. The recall was initiated on 10 Nov 2014 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0964-2015
- FDA event ID
- 70840
- Recalling firm
- Reckitt Benckiser, Parsippany, NJ
- Brand
- Mucinex Dm
- Manufacturer
- Reckitt Benckiser LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Nov 2014
- FDA classified
- 21 Apr 2015
- Reported
- 29 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Cold & Cough Medicine
Timeline
| 10 Nov 2014 | Recall initiated by company | |
| 21 Apr 2015 | Classified by FDA | +162 days |
| 29 Apr 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tablets per pouch (NDC 63824-056-72), OTC, Distributed by Reckitt Benckiser, Parsippany, NJ 07054-0224 Made in England
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch
Which lots are affected?
Lot BD375 exp 06/2016; BD566, BD661 exp. 08/2016
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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