12-Hour Sinus Nasal Spray (Lee) – Microbial Contamination (2012)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled as a) 12 HOUR SINUS Nasal Spray, Best Choice, Proudly Distributed By: Valu Merchandisers, Co., Kansas City, MO 64111, UPC 0 70038 61226 1; b) Nasal Spray Sinus, Distributed by Discount Drug Mart, Medina, Ohio 44258, UPC 0 9335112623 9; c) sinus relief nasal spray, Distributed By DUANE reade, 440 Ninth Avenue, NY, NY 10001, UPC 6 39194 04551 3; d) 12 Hour Nasal Relief Sinus Nasal Spray, Distributed by: Lee
Brand
Lee Pharmaceuticals, Inc
Lot Codes / Batch Numbers
Lot #: 2111 and 2114, Exp 04/14
Products Sold
Lot #: 2111 and 2114, Exp 04/14
Lee Pharmaceuticals, Inc is recalling 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled as a) 12 HO due to Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination . This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination identified during testing.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026