FDA Drug recall D-0149-2023
Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045
- FDA Drug
- Class II
- ongoing
- Published 2023-01-25
On 2023-01-25 the FDA classified a Class II recall of Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045 by Akorn, citing CGMP Deviations:.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0149-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-13 |
| Published | 2023-01-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
Product
Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12
Reason
CGMP Deviations:
Identifiers
| code_info | Lot: 0L48A, EXP 10/31/2022; 0L55A, EXP 10/31/2022; 1C75A, EXP 2/28/2023; 1E18A, 1E20A , EXP 4/30/2023; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0149-2023%22
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