CLASS II Drug recall · Reported 19 Apr 2017 · FDA Enforcement Report
Latanoprost Ophthalmic Solution, 005%, 125 ug recalled by Akorn
Akorn is recalling Latanoprost Ophthalmic Solution, 005%, 125 ug, distributed nationwide in the US. The recall was initiated on 17 Mar 2017 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
| 17 Mar 2017 | Recall initiated by company | |
| 11 Apr 2017 | Classified by FDA | +25 days |
| 19 Apr 2017 | 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
Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
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
LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12
Where it was distributed
Nationwide
Questions about this recall
Is Latanoprost Ophthalmic Solution, 005%, 125 ug recalled?
Yes. Akorn recalled Latanoprost Ophthalmic Solution, 005%, 125 ug on 17 Mar 2017. The recall is Class II and its status is Terminated. Recall number D-0661-2017.
Why was it recalled?
Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
Which lots are affected?
Lot # LAB15G52, LAB11G52, Exp 6/17; LAB18I52, Exp 8/17; LAB9L52, 11/17; LAB1A62, LAB9A62, Exp 12/17
Where was it sold?
Nationwide
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.
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, 005% (Scalp Solution) recalled by Akorn | 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 Latanoprost ophthalmic recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Latanoprost Ophthalmic Solution, 005% (125 mcg recalled by Apotex | Apotex | Sterility | Nationwide |