Oxymetazoline Hcl

Oxymetazoline Hcl recalls: 9 FDA reports

Recalls involving Oxymetazoline Hcl. What was wrong with each batch, and how the FDA graded the risk.

9Reports
0Class I
0Ongoing
2022-03-02Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II9
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SU

D-0623-2022  ·  Class II  ·  reported 2022-03-02  ·  Terminated

Why it was recalled
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Product
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-703-10
Where it went
Nationwide in the USA
How much
1,560 bottles

Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle,

D-0624-2022  ·  Class II  ·  reported 2022-03-02  ·  Terminated

Why it was recalled
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Product
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10
Where it went
Nationwide in the USA
How much
36,864 bottles

No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TO

D-0625-2022  ·  Class II  ·  reported 2022-03-02  ·  Terminated

Why it was recalled
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Product
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007. NDC 36800-388-10
Where it went
Nationwide in the USA
How much
13,824 bottles

No Drip Nasal Decongestant, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: BETTER LIVING

D-0622-2022  ·  Class II  ·  reported 2022-03-02  ·  Terminated

Why it was recalled
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Product
No Drip Nasal Decongestant, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: BETTER LIVING BRANDS LLC, P.O. BOX 99, PLEASANTON, CA 94566-0009. NDC 21130-801-10
Where it went
Nationwide in the USA
How much
11,088 bottles

Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle,

D-0619-2022  ·  Class II  ·  reported 2022-03-02  ·  Terminated

Why it was recalled
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Product
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-388-10
Where it went
Nationwide in the USA
How much
10,800 bottles

Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle,

D-0620-2022  ·  Class II  ·  reported 2022-03-02  ·  Terminated

Why it was recalled
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Product
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10
Where it went
Nationwide in the USA
How much
3,744 bottles

No Drip Nasal Mist, Oxymetazoline HCl 0.05% Nasal decongestant, 1 FL Oz (30 mL) per bottle, Distributed by: C

D-0615-2022  ·  Class II  ·  reported 2022-03-02  ·  Terminated

Why it was recalled
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Product
No Drip Nasal Mist, Oxymetazoline HCl 0.05% Nasal decongestant, 1 FL Oz (30 mL) per bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-388-10
Where it went
Nationwide in the USA
How much
64,512 bottles

No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: W

D-0626-2022  ·  Class II  ·  reported 2022-03-02  ·  Terminated

Why it was recalled
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Product
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. NDC 49035-388-10
Where it went
Nationwide in the USA
How much
178,128 bottles

Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KR

D-0617-2022  ·  Class II  ·  reported 2022-03-02  ·  Terminated

Why it was recalled
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Product
Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10
Where it went
Nationwide in the USA
How much
7,632 bottles
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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