ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0 — Class II drug recall D-0138-2023
Ongoing recall by Akorn, Inc., reported 2023-01-25, distributed nationwide. CGMP Deviations:
| Recall number | D-0138-2023 |
|---|---|
| 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 | 1,109,600 tubes |
| Reason classes | cgmp |
| NDC | 17478-0070-35 |
| Lot numbers | 0L58A, 1B21A, 1B31A, 1C44A, 1C57A, 1C58A, 1C58B, 1E13A, 1E24A, 1G60A, 1G62A, 1G63A, 1J21A, 1J34B, 1J40A, 1K74A, 1L93A, 1L96A, 1L96B, 1M24A, 1M25A, 1M31A, 2A02A, 2A10A, 2C07A, 2D47A, 2E50A, 2E51A |
| Expiration dates | 2022-10-31, 2023-01-31, 2023-02-28, 2023-04-30, 2023-06-30, 2023-08-31, 2023-09-30, 2023-10-31, 2023-11-30, 2023-12-31, 2024-02-29, 2024-03-31, 2024-04-30 |
Product
ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35
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-0138-2023. 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.