Vancomycin Hydrochloride for Oral Solution — Class I drug recall D-0442-2024
Terminated recall by Amneal Pharmaceuticals of New York, LLC, reported 2024-04-24, distributed nationwide. Superpotent Drug: Due to overfilling of drug powder
| Recall number | D-0442-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC, Brookhaven, NY, United States |
| Recall initiated | 2024-03-21 |
| Classified | 2024-04-12 |
| Reported by FDA | 2024-04-24 |
| Terminated | 2025-07-21 |
| Distributed | Nationwide (US) |
| Quantity | 821 bottles |
| Reason classes | potency |
| NDC | 69238-2261, 69238-2261-03, 69238-2261-05, 69238-2261-07 |
| Lot numbers | 22613003A, 22613004A, 22613005A, 22613005B |
| Expiration dates | 2025-09-30 |
Product
Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Reason for recall
Superpotent Drug: Due to overfilling of drug powder
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-0442-2024. 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.