FDA Drug recall D-1471-2022
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest,…
- FDA Drug
- Class III
- ongoing
- Published 2022-09-07
On 2022-09-07 the FDA classified a Class III recall of Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest,… by Akorn, citing failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1471-2022 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2022-08-08 |
| Published | 2022-09-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
Product
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24
Reason
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Identifiers
| code_info | Lot #: 9N72, EXP 09/30/2022 |
|---|
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-1471-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.