CLASS II ONGOING Drug recall · Reported 2 Jul 2025 · FDA Enforcement Report
Azelastine HCl Ophthalmic Solution recalled by Apotex
Apotex is recalling Azelastine HCl Ophthalmic Solution, USP, 05%, distributed nationwide in the US. The recall was initiated on 28 May 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0495-2025
- FDA event ID
- 96954
- Recalling firm
- Apotex, Weston, FL
- Manufacturer
- Apotex Corp.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 May 2025
- FDA classified
- 25 Jun 2025
- Reported
- 2 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 28 May 2025 | Recall initiated by company | |
| 25 Jun 2025 | Classified by FDA | +28 days |
| 2 Jul 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4
Where it was distributed
US Nationwide.
Questions about this recall
Is Azelastine HCl Ophthalmic Solution, USP, 05% recalled?
Yes. Apotex recalled Azelastine HCl Ophthalmic Solution, USP, 05% on 28 May 2025. The recall is Class II and its status is Ongoing. Recall number D-0495-2025.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Batch VD1654, Exp Date: 06/30/2027
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 5mg recalled by ApotexPaxil | Apotex | Potency & Assay | Nationwide |
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| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
Other Azelastine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Azelastine HCl Nasal Solution (Nasal Spray) 1% (137 mcg per spray) recalledAzelastine Hydrochloride | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Azelastine HCl Nasal Solution, 1 %, 137 mcg/spray bottle recalledAzelastine Hydrochloride | Apotex | Manufacturing (CGMP) Deviations | Nationwide |