CLASS II Drug recall · Reported 6 Feb 2019 · FDA Enforcement Report
Gentamicin Sulfate Ophthalmic Solution, USP 0.3% dropper recalled
Akorn is recalling Gentamicin Sulfate Ophthalmic Solution, USP 0.3% dropper, distributed nationwide in the US. The recall was initiated on 8 Oct 2018 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-0414-2019
- FDA event ID
- 81193
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Oct 2018
- FDA classified
- 28 Jan 2019
- Reported
- 6 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Eye Drops
Timeline
| 8 Oct 2018 | Recall initiated by company | |
| 28 Jan 2019 | Classified by FDA | +112 days |
| 6 Feb 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Product as listed by the FDA
Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
Where it was distributed
Nationwide USA and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Which lots are affected?
Lots: 6C02A Exp. 02/19; 5K42A Exp. 09/2018; 7D47A Exp. 03/2020
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.
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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 | Lidocaine Ointment USP, 5%, 1 tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
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Other Gentamicin recalls
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gentamicin Injection, USP, (Pediatric), 20 mg recalled by Eugia USGentamicin | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin Sulfate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin Sulfate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin Sulfate Ointment USP 0.1%, packaged as a) tube recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin 80mg/ Irrigation, containers recalled | The Medicine Shoppe Pharmacy | Sterility | FL |