FDA Drug recall D-0153-2024
Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57)…
- FDA Drug
- Class I
- terminated
- Published 2023-12-27
On 2023-12-27 the FDA classified a Class I recall of Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57)… by The Harvard Drug Group, citing failed Content Uniformity Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0153-2024 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2023-10-23 |
| Published | 2023-12-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Harvard Drug Group |
| Distribution | US |
Product
Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152
Reason
Failed Content Uniformity Specifications
Identifiers
| code_info | Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0153-2024%22
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