CLASS III ONGOING Drug recall · Reported 13 Nov 2024 · FDA Enforcement Report
Kids' Cough and Chest Congestion (Dextromethorphan HBr recalled
Denison Pharmaceuticals is recalling Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg). The recall was initiated on 25 Sep 2024 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-0034-2025
- FDA event ID
- 95430
- Recalling firm
- Denison Pharmaceuticals, Lincoln, RI
- Manufacturer
- Genexa Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 25 Sep 2024
- FDA classified
- 1 Nov 2024
- Reported
- 13 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Cold & Cough Medicine
Timeline
| 25 Sep 2024 | Recall initiated by company | |
| 1 Nov 2024 | Classified by FDA | +37 days |
| 13 Nov 2024 | 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
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the 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
Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018
Where it was distributed
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Questions about this recall
Why was it recalled?
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Which lots are affected?
Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025
Where was it sold?
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
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.
Other products in this recall event
1 other product · FDA event 95430This product is part of a recall event; the main page for the event is Adult Cough and Chest Congestion recalled by Denison Pharmaceuticals.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Adult Cough and Chest Congestion recalled by Denison PharmaceuticalsMaximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack | Denison Pharmaceuticals | Packaging Defects | RI |
More recalls from Denison Pharmaceuticals
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel recalledZapzyt Acne Treatment Gel | Denison Pharmaceuticals | Benzene | Nationwide |
| Drug | CLASS III | Adult Cough and Chest Congestion recalled by Denison PharmaceuticalsMaximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack | Denison Pharmaceuticals | Packaging Defects | RI |
| Drug | CLASS II | Little Remedies Gas Relief Drops (Simethicone/Antigas) recalledLittle Remedies | Denison Pharmaceuticals | Sterility | RI |
| Drug | CLASS II | Safe tussin DM, DAY TIME Cough Relief recalled | Denison Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine recalled | Denison Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
Other Dextromethorphan Hbr recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Adult Cough and Chest Congestion recalled by Denison PharmaceuticalsMaximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack | Denison Pharmaceuticals | Packaging Defects | RI |
| Drug | CLASS II | Rompe Pecho DM recalled by Efficient LaboratoriesRompe Pecho | Efficient Laboratories | Sterility | Nationwide |
| Drug | CLASS II | Rompe Pecho CF Cold & Flu Advanced Formula recalledRompe Pecho | Efficient Laboratories | Sterility | Nationwide |
| Drug | CLASS II | Childrens Robitussin Honey Cough and Chest Congestion DM recalledChildrens Robitussin Honey Cough And Chest Congestion Dm | Glaxosmithkline Consumer Healthcare Holdings | Other | Nationwide |
| Drug | CLASS I | Pecgen DMX Cough Suppressant Expectorant recalled by Novis PRPecgen Dmx | Novis PR | Other | PR |