Neomycin Sulfate Tablets — Class II drug recall D-0328-2021
Terminated recall by X-Gen Pharmaceuticals Inc., reported 2021-04-14, distributed nationwide. Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
| Recall number | D-0328-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | X-Gen Pharmaceuticals Inc., Horseheads, NY, United States |
| Recall initiated | 2021-03-19 |
| Classified | 2021-04-08 |
| Reported by FDA | 2021-04-14 |
| Terminated | 2022-12-07 |
| Distributed | Nationwide (US) |
| Reason classes | microbial contamination, potency, specification failure |
| NDC | 39822-0310-05 |
| Expiration dates | 2022-09 |
Product
Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5
Reason for recall
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
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-0328-2021. 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.