The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1304-2019·Announced 2019-05-22

CVS Health Children's Nasal Saline Drops Recalled for B. cepacia Risk

Unipharma, LLC is recalling CVS Health Children's Nasal Saline Drops due to potential contamination with B. cepacia bacteria.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and is explicitly described as a precautionary measure due to potential contamination, with no reported illnesses or injuries.

Plain-English summary

Unipharma, LLC is recalling CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use. The recall involves 23,712 cartons of the 0.05 fl. oz. (1.5 mL) single-use drops, distributed by CVS Pharmacy, Inc. The affected lots are 80026 (Exp. 05/31/20) and 80027 (Exp. 07/31/20). The product was distributed nationwide and in Venezuela.

The recall is a precautionary measure taken due to Current Good Manufacturing Practice (CGMP) deviations that created a potential risk of product contamination with the bacteria B. cepacia. No illnesses or injuries have been reported in connection with this recall.

Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If you have this product, you should stop using it and follow the instructions provided by the recalling firm or retailer for disposal or return.

The recalled product

Product
CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207
Manufacturer
Unipharma, Llc.
Category
Drug — Nasal Saline
Hazard
Affected units
23,712

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 (2)

  • Lots: 80026 Exp. 05/31/20
  • 80027 Exp. 07/31/20

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Unipharma, Llc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

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