Timolol Maleate Ophthalmic Solution — Class II drug recall D-0156-2023
Ongoing recall by Akorn, Inc., reported 2023-01-25, distributed nationwide. CGMP Deviations:
| Recall number | D-0156-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Gurnee, IL, United States |
| Recall initiated | 2022-10-13 |
| Classified | 2023-01-13 |
| Reported by FDA | 2023-01-25 |
| Distributed | Nationwide (US) |
| Quantity | 1,310,324 bottles |
| Reason classes | cgmp |
| NDC | 17478-0288-10, 17478-0288-11, 17478-0288-12 |
| Lot numbers | 0B50A, 0B59A, 0B69A, 0C74A, 0C82A, 0D04A, 0E37A, 0E49A, 0G07A, 0G14A, 0G82A, 0G84A, 0H26A, 0H28A, 0H36A, 0H38A, 0H49A, 0H53A, 0J58A, 0J64A, 0J66A, 0J75A, 0J77A, 0J84A, 0K03A, 0K04A, 0K05A, 0K06A, 0K96A, 0K98A, 0K99A, 0L46A, 0L57A, 0L59A, 0L72A, 0L74A, 0M80A, 0M81A, 0M82A, 0M83A and 17 more |
| Expiration dates | 2023-01-31, 2023-02-28, 2023-03-31, 2023-04-30, 2023-06-30, 2023-07-31, 2023-08-31, 2023-09-30, 2023-10-31, 2023-11-30, 2023-12-31, 2024-01-31, 2024-02-29, 2024-03-31, 2024-06-30, 2024-08-31 |
Product
Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
Reason for recall
CGMP Deviations:
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-0156-2023. 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.