CLASS III Drug recall · Reported 12 Mar 2014 · FDA Enforcement Report
Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid recalled
Aaron Industries is recalling Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, distributed nationwide in the US. The recall was initiated on 4 Feb 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-1097-2014
- FDA event ID
- 67434
- Recalling firm
- Aaron Industries, Lynwood, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Feb 2014
- FDA classified
- 28 Feb 2014
- Reported
- 12 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Drug class
- Cold & Cough Medicine
Timeline
| 4 Feb 2014 | Recall initiated by company | |
| 28 Feb 2014 | Classified by FDA | +24 days |
| 12 Mar 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.
Product as listed by the FDA
Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg) per 5 mL, 8 FL OZ (237 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-229-08, UPC 6 81131 03884 3.
Where it was distributed
Nationwide
Stores named: Walmart
Questions about this recall
Why was it recalled?
Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.
Which lots are affected?
Lot #: 151631, Exp 10/15 and 152767, Exp 11/15
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.
More recalls from Aaron Industries
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Maximum Strength/Non-Drowsy Tussin DM Adult Maximum recalled | Aaron Industries | Packaging Defects | Nationwide |
| Drug | CLASS III | Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief recalled | Aaron Industries | Particulate Matter | Nationwide |
| Drug | CLASS III | Well at Walgreens Wal-Tussin CF Max recalled by Aaron Industries | Aaron Industries | Particulate Matter | Nationwide |
| Drug | CLASS III | Wal-Mart Equate Tussin CF Adult Maximum Strength recalled | Aaron Industries | Particulate Matter | Nationwide |
| Drug | CLASS III | Select Cough Control CF Max, Maximum Strength recalled | Aaron Industries | Particulate Matter | Nationwide |