CLASS II ONGOING Drug recall · Reported 7 Jun 2023 · FDA Enforcement Report
Olopatadine HCl Ophthalmic Solution recalled by Akorn
Akorn is recalling Olopatadine HCl Ophthalmic Solution, USP, 2%, distributed nationwide in the US. The recall was initiated on 26 Apr 2023 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
Timeline
| 26 Apr 2023 | Recall initiated by company | |
| 1 Jun 2023 | Classified by FDA | +36 days |
| 7 Jun 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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
Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Is Olopatadine HCl Ophthalmic Solution, USP, 2% recalled?
Yes. Akorn recalled Olopatadine HCl Ophthalmic Solution, USP, 2% on 26 Apr 2023. The recall is Class II and its status is Ongoing. Recall number D-0860-2023.
Why was it recalled?
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Which lots are affected?
All Lots
Where was it sold?
Nationwide in the USA and Puerto Rico
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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Other Olopatadine hcl ophthalmic recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Olopatadine HCl Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Olopatadine HCl Ophthalmic Solution recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Olopatadine HCl Ophthalmic Solution, USP 1% per dropper recalled | Akorn | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Olopatadine HCL Ophthalmic Solution recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Olopatadine HCl Ophthalmic Solution recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |