CLASS II Drug recall · Reported 2 Mar 2022 · FDA Enforcement Report
Maximum Strength Plus Menthol No Drip Nasal Spray recalled
Perrigo Company is recalling Maximum Strength Plus Menthol No Drip Nasal Spray, Oxymetazoline HCl 05% Nasal, distributed nationwide in the US. The recall was initiated on 26 Oct 2021 and the FDA has classified it as Class II.
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-0603-2022
- FDA event ID
- 88905
- Recalling firm
- Perrigo Company, Allegan, MI
- Manufacturer
- Amazon.com Services LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Oct 2021
- FDA classified
- 23 Feb 2022
- Reported
- 2 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Nasal Sprays
Timeline
| 26 Oct 2021 | Recall initiated by company | |
| 23 Feb 2022 | Classified by FDA | +120 days |
| 2 Mar 2022 | Published 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Product as listed by the FDA
Maximum Strength Plus Menthol No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: AMAZON.COM SERVICES LLC 410 TERRY AVENUE N.SEATTLE, WA 98109. NDC: 72288-703-10
Where it was distributed
Nationwide in the USA
Stores named: Amazon
Questions about this recall
Is Maximum Strength Plus Menthol No Drip Nasal Spray, Oxymetazoline HCl 05% Nasal recalled?
Yes. Perrigo Company recalled Maximum Strength Plus Menthol No Drip Nasal Spray, Oxymetazoline HCl 05% Nasal on 26 Oct 2021. The recall is Class II and its status is Terminated. Recall number D-0603-2022.
Why was it recalled?
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Which lots are affected?
Batch: 1FK1251, Exp 02/28/2023; 1BK0716, Exp 12/31/2022
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.
More recalls from Perrigo Company
All 106| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Children's Pain & Fever Acetaminophen recalled by Perrigo Company | Perrigo Company | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Children's Cherry Flavored Acetaminophen Oral Suspension (160mg recalled | Perrigo Company | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nasal Spray Decongestant, No Drip, Oxymetazoline HCl recalledNasal | Perrigo Company | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Acetaminophen Oral Suspension Grape Flavor, 160 mg recalled | Perrigo Company | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Maximum Strength Nasal Spray recalled by Perrigo CompanyNasal | Perrigo Company | Manufacturing (CGMP) Deviations | Nationwide |
Other Oxymetazoline recalls
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Quality Choice No Drip Severe Congestion Nasal Pump Mist recalledOxymetazoline Hydrochloride | Seaway Pharma | Sterility | MI, PA |
| Drug | CLASS II | Nasal Spray Original No Drip Oxymetazoline HCl Nasal recalledOxymetazoline Hydrochloride | Seaway Pharma | Sterility | MI, PA |
| Drug | CLASS II | Quality Choice No Drip Extra Moisturizing Nasal Pump Mist recalledOxymetazoline Hydrochloride | Seaway Pharma | Sterility | MI, PA |
| Drug | CLASS II | Nasal Spray Decongestant, No Drip, Oxymetazoline HCl recalledNasal | Perrigo Company | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Maximum Strength Nasal Spray recalled by Perrigo CompanyNasal | Perrigo Company | Manufacturing (CGMP) Deviations | Nationwide |