CLASS II Drug recall · Reported 27 Nov 2019 · FDA Enforcement Report
Altaire Diclofenac Sodium Opthalmic Solution recalled
Altaire Pharmaceuticals is recalling Altaire Diclofenac Sodium Opthalmic Solution, 1%, distributed nationwide in the US. The recall was initiated on 2 Jul 2019 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-0461-2020
- FDA event ID
- 83265
- Recalling firm
- Altaire Pharmaceuticals, Aquebogue, NY
- Brand
- Diclofenac
- Manufacturer
- Altaire Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 2 Jul 2019
- FDA classified
- 15 Nov 2019
- Reported
- 27 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 2 Jul 2019 | Recall initiated by company | |
| 15 Nov 2019 | Classified by FDA | +136 days |
| 27 Nov 2019 | Published in enforcement report | +12 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
Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-05
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Is Altaire Diclofenac Sodium Opthalmic Solution, 1% recalled?
Yes. Altaire Pharmaceuticals recalled Altaire Diclofenac Sodium Opthalmic Solution, 1% on 2 Jul 2019. The recall is Class II and its status is Completed. Recall number D-0461-2020.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
17225 07/19 17247 08/19 18038 02/20 18162 06/20 19014 01/21
Where was it sold?
U.S.A. 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.
More recalls from Altaire Pharmaceuticals
All 135| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution recalled | Altaire Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Altaire Sterile Eye Wash, Altaire Pharmaceuticals recalled | Altaire Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Perrigo Neomycin and Polymixin B Sulfates recalled | Altaire Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | OCuSOFT Tetravisc Tetracaine HCl 5% Sterile Anesthetic Single Dose recalled | Altaire Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Walgreens Sodium Chloride Ophthalmic Solution recalledSodium Chloride | Altaire Pharmaceuticals | Sterility | Nationwide |
Other Diclofenac recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diclofenac Sodium, Topical Gel, 3% tube recalledDiclofenac Sodium | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Diclofenac Sodium Topical Gel recalled by Cipla USADiclofenac Sodium | Cipla USA | Other | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution USP, 2% w/w recalledDiclofenac Sodium | Alembic Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Altaire Diclofenac Sodium Opthalmic Solution recalledDiclofenac | Altaire Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Diclofenac Sodium USP for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |