CLASS II ONGOING Drug recall · Reported 25 Jan 2023 · FDA Enforcement Report
Olopatadine HCL Ophthalmic Solution recalled by Akorn
Akorn is recalling Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever per, distributed nationwide in the US. The recall was initiated on 13 Oct 2022 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-0148-2023
- FDA event ID
- 90948
- Recalling firm
- Akorn, Gurnee, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Oct 2022
- FDA classified
- 13 Jan 2023
- Reported
- 25 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Eye Drops
Timeline
| 13 Oct 2022 | Recall initiated by company | |
| 13 Jan 2023 | Classified by FDA | +92 days |
| 25 Jan 2023 | 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
CGMP Deviations:
Product as listed by the FDA
Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations:
Which lots are affected?
Lot: 1L03A, EXP 10/31/2023
Where was it sold?
Nationwide in the USA
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
26 other products · FDA event 90948This product is part of a recall event; the main page for the event is Tobramycin Ophthalmic Solution recalled by Akorn.
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|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
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| Drug | CLASS II | Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Lidocaine Ointment USP, 5%, 1 tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
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Other Olopatadine recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 % recalled | USV Private | Potency & Assay | Nationwide |
| Drug | CLASS II | Ryaltris (olopatadine hydrochloride recalled by Glenmark PharmaceuticalsRyaltris | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS II | Olopatadine HCl Nasal Spray, 665 mcg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| 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 | Potency & Assay | Nationwide |