Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0437-2023·Announced 2023-03-15

FDA Recalls NaturalCare bioAllers Nasal Spray Due to Manufacturing Defects

Nutraceutical Corporation recalls NaturalCare bioAllers Allergy Nasal Spray nationwide due to manufacturing quality deviations in raw materials. The recalled lots show discoloration and do not meet FDA Good Manufacturing Practice standards.

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: This FDA Class II recall involves manufacturing quality deviations without reported illnesses or injuries. The specific hazard—discoloration of raw materials—is not a known pathogen or allergen. The recall appears to be a precautionary manufacturing quality issue.

Plain-English summary

Nutraceutical Corporation is recalling NaturalCare bioAllers Allergy Nasal Spray nationwide. The recall affects 13,974 units distributed throughout the USA due to Good Manufacturing Practice (CGMP) deviations. The raw material supplier had recalled the material due to discoloration.

The affected lots include: 221263 (expires 10/24), 222047 and 222048 (expire 02/25), and 222099 and 222100 (expire 03/25). Consumers should check their products to determine if they have a recalled lot.

Consumers who have purchased this product should not use it. Contact the manufacturer or the place of purchase for instructions on return or disposal.

The recalled product

Product: NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp., NaturalCare Park City, UT, 84098 USA, UPC 3 71400 70801 9
Manufacturer: Nutraceutical Corporation
Category: Drug — Allergy Medication
Hazard: manufacturing-defect
discoloration
Affected units: 13,974

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 (7)

Lot: 221263
Exp: 10/24
222047
222048 Exp: 02/25
222099
222100
Exp: 03/25

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Nutraceutical Corporation 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 4 products in this recall →

Same manufacturer · Nutraceutical Corporation

See all →

High
NaturalCare bioAllers Homeopathic Drops Recalled for Manufacturing Quality Defect
FDA (Drugs) · 2023-03-15
Moderate
NaturalCare Children's Allergy Care Homeopathic Drops Recalled for CGMP Deviation
FDA (Drugs) · 2023-03-15
High
NatraBio Cold and Sinus Nasal Spray Recalled for Manufacturing Deviation
FDA (Drugs) · 2023-03-15

Same hazard · manufacturing defect