CLASS II Drug recall · Reported 8 Sep 2021 · 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 2 Aug 2021 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-0786-2021
- FDA event ID
- 88594
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Aug 2021
- FDA classified
- 31 Aug 2021
- Reported
- 8 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Bacterial Contamination
- Drug class
- Eye Drops
Timeline
| 2 Aug 2021 | Recall initiated by company | |
| 31 Aug 2021 | Classified by FDA | +29 days |
| 8 Sep 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
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 USA and Puerto Rico
Questions about this recall
Why was it recalled?
Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
Which lots are affected?
Lot #: 9G01A, Exp 06/2022; 9H32A, Exp 07/2022; 9K82A, 9K82B, Exp 09/2022
Where was it sold?
Nationwide 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 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.
More recalls from 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 | Manufacturing (CGMP) Deviations | Nationwide |