Erythromycin Ophthalmic Ointment USP — Class II drug recall D-0139-2023
Ongoing recall by Akorn, Inc., reported 2023-01-25, distributed nationwide. CGMP Deviations:
| Recall number | D-0139-2023 |
|---|---|
| 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 | 36,455 cartons |
| Reason classes | cgmp |
| NDC | 17478-0070-31 |
| Lot numbers | 1B14B, 1C49A, 1C49B, 1C70A, 1E09A, 1E09B, 1E34A, 1E34B, 1F37A, 1F37B, 1F37C, 1G57A, 1G57B, 1G58A, 1G58B, 1G66A, 1G66B, 1H77A, 1H77B, 1H80A, 1H80B, 1J24A, 1K67A, 1K67B, 1K76A, 1K76B, 1K77A, 1K77B, 1K87A, 1K87B, 1L90A, 1L90B, 1L92A, 1L92B, 1M28A, 1M28B, 1M35A, 2D20B |
| Expiration dates | 2023-01-31, 2023-02-28, 2023-04-30, 2023-05-31, 2023-06-30, 2023-07-31, 2023-08-31, 2023-09-30, 2023-10-31, 2023-11-30, 2024-03-31 |
Product
Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31
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-0139-2023. 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.