CLASS III Drug recall · Reported 7 May 2014 · FDA Enforcement Report
Maximum Strength/Non-Drowsy Tussin DM Adult Maximum recalled
Aaron Industries is recalling Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, distributed nationwide in the US. The recall was initiated on 11 Apr 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-1286-2014
- FDA event ID
- 68003
- Recalling firm
- Aaron Industries, Lynwood, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Apr 2014
- FDA classified
- 29 Apr 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Drug class
- Cold & Cough Medicine
Timeline
| 11 Apr 2014 | Recall initiated by company | |
| 29 Apr 2014 | Classified by FDA | +18 days |
| 7 May 2014 | 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
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
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
Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, Lancaster, NY 14086, UPC 341520339677, B) Our Family 4 fl oz bottle, Distributed by Nash Finch Company, NFC Brands, MPLS, MN 55435, UPC 070253579523, C) Premier Value 4, 8 fl oz bottle, Distributed by Chain Drug Consortium, LLC., Boca Raton, FL 33431, 4 fl oz UPC 840986024719; 8 fl oz UPC 840986024726, NDC 68016-177-XX, D) Rexall 4 fl oz bottle, Packaged for Dolencorp, LLC, Goodlettsville, TN 37072, UPC 715256714044, E) Safeway 4 fl oz, Distributed by Safeway INC, Pleasanton, CA 94566-0009, UPC 321130763581; F) Select Brand 4, 8 fl oz, Distributed by Select Brand Distributers, Pine Bluff, AR 71603, 4 fl oz UPC 015127024303; 8 fl oz UPC 015127024310.
Where it was distributed
Nationwide
Stores named: Albertsons
Questions about this recall
Why was it recalled?
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
Which lots are affected?
Lot #: 73762, 80030, 82053, 83032, 73768, 76414, 78222, 78441, 140423, 140494, 142396,145460,145959, 73831, 73832, 78440, 79819, 82606, 80969, 140530, 142413, 145461, 74163; Exp 06/14 Lot #:148820, 149396, 149995, 150208, 150422, 150599, 151023, 151071,151337, 148931,151072. ; Exp 08/15
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 | Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid recalled | Aaron Industries | Other | 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 |