Erythromycin Pledgets USP — Class II drug recall D-0385-2015
Terminated recall by Akorn, Inc., reported 2015-02-18, distributed nationwide. Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial t
| Recall number | D-0385-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2015-01-28 |
| Classified | 2015-02-10 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2017-11-30 |
| Distributed | Nationwide (US) |
| Quantity | 23,449 jars |
| Reason classes | microbial contamination, sterility |
| NDC | 61748-0202-60 |
| Lot numbers | 03/15, 05/15, 06/15, 08/15, 1446800, 1538100, 1538101, 1538200, 1608200 |
Product
Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Marietta, GA 30062, NDC 61748-202-60 .
Reason for recall
Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
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-0385-2015. 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.