CLASS II Drug recall · Reported 14 Sep 2022 · FDA Enforcement Report
Lidocaine Hydrochloride Jelly USP, 2%, Sterile tube recalled by Akorn
Akorn is recalling Lidocaine Hydrochloride Jelly USP, 2%, Sterile tube, 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
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-1495-2022
- 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
- Pain Medication
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
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
Where it was distributed
USA 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 # 9J36A, 9J36B, 9J39A, 9J39B, 9J39C, 9J39D, 9J39E, 9J42B, 9J42C, Exp 8/31/2022; 9K62A, 9K62B, 9K62C, Exp 9/30/2022; 9M04A, 9M04B, Exp 11/30/2022
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile recalled by Akorn | Akorn | Sterility | Nationwide |
More recalls from Akorn
All 192| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 Lidocaine Jelly recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lidocaine HCl Jelly USP, 2% tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) tube recalled | Akorn | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Lidocaine HCL (sterile) 4% Jelly recalled by Franck's Lab Inc., d.b.a. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Sterility | Nationwide |