CLASS II ONGOING Drug recall · Reported 7 Jun 2023 · FDA Enforcement Report

Safe tussin DM, DAY TIME Cough Relief recalled

Denison Pharmaceuticals is recalling Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP, distributed nationwide in the US. The recall was initiated on 3 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 8314, Exp: 04/2023, 8753, 8753A, Exp: 10/2023; 8659, Exp: 08-2023
Quantity recalled86,616 4 OZ bottles

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-0772-2023
FDA event ID
92268
Recalling firm
Denison Pharmaceuticals, Lincoln, RI
Classification
Class II
Status
Ongoing
Recall initiated
3 May 2023
FDA classified
31 May 2023
Reported
7 Jun 2023
Type
Voluntary: Firm initiated
Customers notified by
Letter

Timeline

3 May 2023Recall initiated by company
31 May 2023Classified by FDA+28 days
7 Jun 2023Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Product as listed by the FDA

Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.

Where it was distributed

Product was distributed Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Which lots are affected?

Lot: 8314, Exp: 04/2023, 8753, 8753A, Exp: 10/2023; 8659, Exp: 08-2023

Where was it sold?

Product was distributed 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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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

3 other products · FDA event 92268

This product is part of a recall event; the main page for the event is Pin-Away Pyrental Pamoate (Pyrantel base 50 mg / mL) recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIPin-Away Pyrental Pamoate (Pyrantel base 50 mg / mL) recalledDenison PharmaceuticalsManufacturing (CGMP) DeviationsNationwide
CLASS IISafe tussin PM, Night Time Cough Relief recalledDenison PharmaceuticalsManufacturing (CGMP) DeviationsNationwide
CLASS IIColic Calm, Colic, Gas & Reflux, Homeopathic Medicine recalledDenison PharmaceuticalsManufacturing (CGMP) DeviationsNationwide

More recalls from Denison Pharmaceuticals

All 8
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIZapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel recalledZapzyt Acne Treatment GelDenison PharmaceuticalsBenzeneNationwide
DrugCLASS IIIKids' Cough and Chest Congestion (Dextromethorphan HBr recalledMaximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo PackDenison PharmaceuticalsPackaging DefectsRI
DrugCLASS IIIAdult Cough and Chest Congestion recalled by Denison PharmaceuticalsMaximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo PackDenison PharmaceuticalsPackaging DefectsRI
DrugCLASS IILittle Remedies Gas Relief Drops (Simethicone/Antigas) recalledLittle RemediesDenison PharmaceuticalsSterilityRI
DrugCLASS IIColic Calm, Colic, Gas & Reflux, Homeopathic Medicine recalledDenison PharmaceuticalsManufacturing (CGMP) DeviationsNationwide