FDA Drug recall D-0442-2024
Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3
- FDA Drug
- Class I
- terminated
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class I recall of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3 by Amneal Pharmaceuticals, citing superpotent Drug: Due to overfilling of drug powder.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0442-2024 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2024-03-21 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | US |
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
Superpotent Drug: Due to overfilling of drug powder
Identifiers
| ndc | 69238-2261-3 |
|---|---|
| ndc | 69238-2261-7 |
| ndc | 69238-2261-5 |
| code_info | Lot # (a) 22613003A, Exp. date 09/30/2025; (b) 22613004A, 22613005A, Exp. date 09/30/2025; (c) 22613005B, Exp. date 09/30/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class I · 2026-04-08 · Amneal Pharmaceuticals
All Amneal Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0442-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.