CLASS II Drug recall · Reported 24 Oct 2018 · FDA Enforcement Report

Walgreens, NO DRIP Severe Anefrin Nasal Spray recalled

Product Quest Manufacturing is recalling Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 05%) Nasal Decongestant, distributed nationwide in the US. The recall was initiated on 3 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots remaining within expiry.
Quantity recalled533,016 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-0064-2019
FDA event ID
80750
Recalling firm
Product Quest Manufacturing, Daytona Beach, FL
Classification
Class II
Status
Terminated
Recall initiated
3 Aug 2018
FDA classified
16 Oct 2018
Reported
24 Oct 2018
Type
Voluntary: Firm initiated
Customers notified by
Letter
Drug class
Nasal Sprays

Timeline

3 Aug 2018Recall initiated by company
16 Oct 2018Classified by FDA+74 days
24 Oct 2018Published 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

CGMP Deviations: products manufactured under conditions that could impact its product quality.

Product as listed by the FDA

Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour + Menthol, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7001-01, UPC 3 11917 18536 1.

Where it was distributed

Nationwide in the USA

Nationwide

Stores named: Walgreens

Questions about this recall

Is Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 05%) Nasal Decongestant recalled?

Yes. Product Quest Manufacturing recalled Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 05%) Nasal Decongestant on 3 Aug 2018. The recall is Class II and its status is Terminated. Recall number D-0064-2019.

Why was it recalled?

CGMP Deviations: products manufactured under conditions that could impact its product quality.

Which lots are affected?

All lots remaining within expiry.

Where was it sold?

Nationwide in the USA

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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