Cromolyn Sodium Ophthalmic Solution — Class II drug recall D-0137-2023
Ongoing recall by Akorn, Inc., reported 2023-01-25, distributed nationwide. CGMP Deviations:
| Recall number | D-0137-2023 |
|---|---|
| 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 | 188,550 bottles |
| Reason classes | cgmp |
| NDC | 17478-0291-11 |
| Lot numbers | 0G12A, 0G75A, 0H50A, 0J88A, 1D97A, 1D98A, 1E31A, 1H14A |
| Expiration dates | 2023-06-30, 2023-07-31, 2023-08-31, 2024-03-31, 2024-04-30, 2024-07-31 |
Product
Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11
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-0137-2023. 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.