Timolol Maleate Ophthalmic Solution — Class III drug recall D-1471-2022
Ongoing recall by Akorn, Inc, reported 2022-09-07, distributed nationwide. Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability
| Recall number | D-1471-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc, Gurnee, IL, United States |
| Recall initiated | 2022-08-08 |
| Classified | 2022-08-29 |
| Reported by FDA | 2022-09-07 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 17478-0189-24 |
| Lot numbers | 9N72 |
| Expiration dates | 2022-09-30 |
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 for recall
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1471-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.