CLASS II ONGOING Drug recall · Reported 25 Jan 2023 · FDA Enforcement Report
Artificial Tears Ointment, Lubricant Eye Ointment recalled by Akorn
Akorn is recalling Artificial Tears Ointment, Lubricant Eye Ointment, 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-0133-2023
- 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
Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations:
Which lots are affected?
Lot # 0A08B, EXP 12/31/2022; 0B63A, EXP 1/31/2023; 0C72A, EXP 2/28/2023; 0D14A, 0D19A, EXP 3/31/2023; 0F54A, EXP 5/31/2023; 0G80B, 0G09B, 0G97A, EXP 6/30/2023; 0J78A, EXP 8/31/2023; 0K23A, EXP 9/30/2023; 0L64A, EXP 10/31/2023;1B29A, EXP 1/31/2024; 1C59A, 1C53A, 1C72A,1C78A, EXP 2/29/2024; 1D87A, 1D89A, EXP 3/31/2024; 1G59A, 1G59B, EXP 6/30/2024; 1K60A, EXP 9/30/2024; 1J57A, EXP 8/31/2024; 1H86A, EXP 7/31/2024; 1K75A, EXP 9/30/2024; 1L12A, EXP 10/31/2024; 1M22A, EXP 11/30/2024
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 |
| Drug | CLASS II | Calcipotriene Topical Solution, 0.005% (Scalp Solution) recalled | Akorn | Potency & Assay | Nationwide |
| 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 |
| Drug | CLASS II | Midazolam Injection, USP 2mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
Other Artificial Tears recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Artificial Tears Ophthalmic Solution recalled by BRS Analytical ServicesArtificial Tears | BRS Analytical Services | Sterility | Nationwide |
| Drug | CLASS II | Artificial Tears Solution, Polyvinyl Alcohol recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Artificial Tears Ointment, Sterile, For Ophthalmic Use Only tubes recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Artificial Tears Solution, Lubricant Eye Drops recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Artificial Tears Ointment, Lubricant Eye Ointment recalled by Akorn | Akorn | Other Bacterial Contamination | Nationwide |