Saline nasal spray recalled over microbial contamination with Pseudomonas lactis
Medical Products Laboratories is recalling 41,328 bottles of Walgreens Saline Nasal Spray with Xylitol over microbial contamination identified as Pseudomonas lactis.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a named microbial contaminant in a product applied to the nasal mucosa is a hazard, and no illnesses are reported.
Plain-English summary
Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45 mL) bottles, distributed by Walgreen Co. of Deerfield, Illinois, NDC 0363-3114-01, is being recalled for microbial contamination of a non-sterile product, with the microorganism identified as Pseudomonas lactis.
The recall covers 41,328 bottles from lot 71409 (expiring 28 February 2027) and lot 71861 (expiring 31 August 2027). The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The product is sprayed into the nose, so contamination is delivered onto mucous membranes. The enforcement record names the organism and reports no illnesses.
Anyone holding a bottle from an affected lot should stop using it and follow the retailer's instructions.
The recalled product
- Product
- Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01
- Manufacturer
- Medical Products Laboratories, Inc.
- Category
- Drug — Nasal spray
- Affected units
- 41,328
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot#: 71409
- Expires: 02/28/2027
- 71861
- Expires: 08/31/2027.
Distribution
Distributed nationwide across the United States.
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