CLASS II Drug recall · Reported 14 Sep 2022 · FDA Enforcement Report

Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile recalled by Akorn

Akorn is recalling Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, distributed nationwide in the US. The recall was initiated on 31 Aug 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot#: 9J58A, 9J58B, Exp 8/31/2022

Quantity recalled48,636 tubes

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-1496-2022
FDA event ID: 90813
Recalling firm: Akorn, Gurnee, IL
Classification: Class II
Status: Terminated
Recall initiated: 31 Aug 2022
FDA classified: 6 Sep 2022
Reported: 14 Sep 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Eye Drops

Timeline

31 Aug 2022	Recall initiated by company
6 Sep 2022	Classified by FDA	+6 days
14 Sep 2022	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

cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.

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

Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35

Where it was distributed

USA nationwide

Nationwide

Questions about this recall

Why was it recalled?

cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.

Which lots are affected?

Lot#: 9J58A, 9J58B, Exp 8/31/2022

Where was it sold?

USA 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 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

1 other product · FDA event 90813

This product is part of a recall event; the main page for the event is Lidocaine Hydrochloride Jelly USP, 2%, Sterile tube recalled by Akorn.

Reported	Class	Recall	Company	Reason	Where
14 Sep 2022	CLASS II	Lidocaine Hydrochloride Jelly USP, 2%, Sterile tube recalled by Akorn	Akorn	Sterility	Nationwide

More recalls from Akorn

All 192

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Timolol Maleate Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Calcipotriene Topical Solution, 0.005% (Scalp Solution) recalled	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Lidocaine Ointment USP, 5%, 1 tubes recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Midazolam Injection, USP 2mg recalled by Akorn	Akorn	Potency & Assay	Nationwide

Other Sodium Chloride recalls

All 133

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride	B Braun Medical	Particulate Matter	Nationwide
9 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride	Baxter Healthcare	Particulate Matter	IL
2 Sep 2026Drug	CLASS I	Lactated Ringer's Injection USP Excel container recalledLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
13 May 2026Drug	CLASS I	Lactated Ringer's Injection USP container recalled by B Braun MedicalLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
29 Apr 2026Drug	CLASS II	Lactated Ringer's Irrigation, Sterile, Ex only recalledLactated Ringers Irrigation	B Braun Medical	Sterility	Nationwide