CLASS III Drug recall · Reported 29 May 2013 · FDA Enforcement Report
Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief recalled
Aaron Industries is recalling Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10, distributed nationwide in the US. The recall was initiated on 4 Apr 2013 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-419-2013
- FDA event ID
- 52863
- Recalling firm
- Aaron Industries, Lynwood, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Apr 2013
- FDA classified
- 17 May 2013
- Reported
- 29 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Cold & Cough Medicine
Timeline
| 4 Apr 2013 | Recall initiated by company | |
| 17 May 2013 | Classified by FDA | +43 days |
| 29 May 2013 | 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; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Product as listed by the FDA
Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8.
Where it was distributed
Nationwide in the US: MD, MI, AL, NC, CT, NY, PA, OR, WV.
Nationwide AlabamaConnecticutMarylandMichiganNorth CarolinaNew YorkOregonPennsylvaniaWest Virginia
Stores named: Rite Aid
Questions about this recall
Why was it recalled?
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Which lots are affected?
Lot # 82507 and 82720.
Where was it sold?
Nationwide in the US: MD, MI, AL, NC, CT, NY, PA, OR, WV.
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 | Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid recalled | Aaron Industries | Other | 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 |