Agency classClass IIIOur severity:Low FDA (Drugs)·D-1667-2012·Announced 2012-09-05

Apotex Recalls Azelastine Hydrochloride Nasal Solution Due to CGMP Deviations

Apotex Corp. is recalling Azelastine Hydrochloride Nasal Solution because tubing used for filling may interact with the nasal formulation.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The source text explicitly classifies the recall as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Apotex Corp. is recalling Azelastine Hydrochloride Nasal Solution, 0.1%, 137 mcg/spray, 30 mL bottles (NDC 60505-0833-5). The recall involves 963,407 bottles distributed nationwide and in Puerto Rico. Affected lot numbers include JK9130, JM0925 (Exp 05/12), JN6514 (Exp 07/12), JN1125, JN1127 (Exp 08/12), and JR5780, JR5782 (Exp 12/12).

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the tubing used for filling the product may interact with the nasal formulation. This is classified as an FDA Class III recall, indicating that the product is not likely to cause adverse health consequences.

Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase. No specific instructions for disposal or replacement are provided in the source text.

The recalled product

Product: AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
Brand: AZELASTINE HYDROCHLORIDE
Manufacturer: Apotex Corp.
Category: Drug — Nasal Spray
Hazard: cgmp-deviation
tubing-interaction
Affected units: 963,407

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 (11)

Lot #: JK9130
JM0925
Exp 05/12
JN6514
Exp 07/12
JN1125
JN1127
Exp 08/12
JR5780
JR5782
Exp 12/12.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same brand · AZELASTINE HYDROCHLORIDE

Severe
Azelastine Hydrochloride Ophthalmic Solution Recalled Due to Sterility
FDA (Drugs) · 2025-07-02
Low
Sun Pharmaceutical Recalls Azelastine HCl Nasal Spray for Stability Test Failure
FDA (Drugs) · 2018-02-21

Same manufacturer · Apotex Corp.

See all →

Moderate
Apotex Recalls Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
Moderate
Apotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
Moderate
Apotek desmopressin nasal spray recalled over dislodged or missing cap liners
FDA (Drugs) · 2026-04-22
High
Brimonidine and timolol eye drops recalled over sterility assurance failure
FDA (Drugs) · 2026-03-25
High
Glaucoma eye drops recalled over sterility assurance and bottle sealing concerns
FDA (Drugs) · 2025-10-08

Same hazard · cgmp deviation