Azelastine Hydrochloride Ophthalmic Solution Recalled Due to Sterility
Apotex Corp. is recalling Azelastine Hydrochloride Ophthalmic Solution, USP 0.05% due to lack of assurance of sterility. The affected batch was distributed nationwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class II. The hazard—lack of sterility assurance in an ophthalmic solution applied directly to the eye—represents a high-risk pathway for serious infection and injury. Although no illnesses have been reported in the source text, the nature of the product and route of administration (direct ocular contact) makes this a severe recall.
Plain-English summary
Apotex Corp. is recalling Azelastine Hydrochloride Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only. The recall affects 105,456 bottles from Batch VD1654 with an expiration date of 06/30/2027. This product is manufactured by Apotex Inc. in Toronto, Ontario, Canada and was distributed nationwide in the United States.
The recall was initiated due to a lack of assurance of sterility. Because this product is a sterile ophthalmic solution intended for direct application to the eye, any compromise in sterility could potentially result in serious complications.
Patients currently using this product from the affected batch should contact their healthcare provider or pharmacist immediately. Do not continue using the product without consulting a healthcare professional. Patients should bring the product to their pharmacy or dispose of it according to their pharmacist's instructions. Healthcare providers and pharmacists should review patient records to identify individuals who may have received this product.
The recalled product
- Product
- AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
- Brand
- AZELASTINE HYDROCHLORIDE
- Manufacturer
- Apotex Corp.
- Category
- Drug — Ophthalmic Solution
- Affected units
- 105,456
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)
- Batch VD1654
- Exp Date: 06/30/2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Apotex Corp. 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.
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