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Oxymetazoline Hydrochloride
Oxymetazoline Hydrochloride recalls: 18 FDA reports
Recalls involving Oxymetazoline Hydrochloride. What was wrong with each batch, and how the FDA graded the risk.
18Reports
0Class I
3Ongoing
2024-01-10Most 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.
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
By year reported
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.
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Dec
D-0216-2024 · Class II · reported 2024-01-10 · Ongoing
- Why it was recalled
- CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
- Product
- Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MI 48375, NDC# 63868-676-01, UPC 6-35515-98847-7.
- Where it went
- MI, PA
- How much
- 7,992 bottles
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a)
D-0214-2024 · Class II · reported 2024-01-10 · Ongoing
- Why it was recalled
- CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
- Product
- Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 63868-607-01, UPC 6-35515-98843-9, b) Premier Value, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne, PA 19087 UPC 8-40986-03509-8.
- Where it went
- MI, PA
- How much
- 7,992 bottles
Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestan
D-0217-2024 · Class II · reported 2024-01-10 · Ongoing
- Why it was recalled
- CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
- Product
- Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0
- Where it went
- MI, PA
- How much
- 8,160 bottles
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DIS
D-0607-2022 · 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
- Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDOVER, MD 20785. NDC 41520-108-10
- Where it went
- Nationwide in the USA
- How much
- 3,192 bottles
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DIS
D-0609-2022 · 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
- Severe Congestion Nasal Spray, No Drip Plus Menthol, 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 21130-813-10
- Where it went
- Nationwide in the USA
- How much
- 14,784 bottles
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle,
D-0613-2022 · 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: AMAZON.COM SERVICES LLC, 410 TERRY AVENUE N. SEATTLE, WA 9810. NDC 72288-388-10
- Where it went
- Nationwide in the USA
- How much
- 1,296 bottles
Severe Congestion No Drip Nasal Spray Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTR
D-0606-2022 · 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
- Severe Congestion No Drip Nasal Spray Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-511-10
- Where it went
- Nationwide in the USA
- How much
- 21,4824 bottles
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle,
D-0614-2022 · 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: AMAZON.COM SERVICES LLC, 410 TERRY AVENUE N. SEATTLE, WA 9810. NDC 72288-388-10
- Where it went
- Nationwide in the USA
- How much
- 26,448 bottles
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DIS
D-0605-2022 · 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
- Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDOVER, MD 20785. NDC 41520-108-10
- Where it went
- Nationwide in the USA
- How much
- 7,200 bottles
Maximum Strength Plus Menthol No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL)
D-0603-2022 · 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 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 went
- Nationwide in the USA
- How much
- 37,104 bottles
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DIS
D-0612-2022 · 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
- Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TOPCO ASSOCIATES LLC., ELK GROVE VILLAGE, IL 60007. NDC 36800-907-10
- Where it went
- Nationwide in the USA
- How much
- 19,584 bottles
Maxiumum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle,
D-0616-2022 · 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
- Maxiumum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-623-10
- Where it went
- Nationwide in the USA
- How much
- 123,408 bottles
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle,
D-0621-2022 · 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: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011. NDC 11822-6319-1
- Where it went
- Nationwide in the USA
- How much
- 15,264 bottles
Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DISTRIBUTED
D-0627-2022 · 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
- Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-696-10
- Where it went
- Nationwide in the USA
- How much
- 79,776 botles
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DIS
D-0608-2022 · 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
- Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011. NDC 11822-6378-1
- Where it went
- Nationwide in the USA
- How much
- 9,888 bottles
Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bot
D-0628-2022 · 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 Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-989-10
- Where it went
- Nationwide in the USA
- How much
- 2,302 bottles
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Dis
D-0610-2022 · 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
- Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-343-10
- Where it went
- Nationwide in the USA
- How much
- 2,664 bottles
Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bot
D-0629-2022 · 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 Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-989-10
- Where it went
- Nationwide in the USA
- How much
- 144 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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