Phenytoin Oral Suspension — Class I drug recall D-0153-2024
Terminated recall by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, reported 2023-12-27, distributed nationwide. Failed Content Uniformity Specifications
| Recall number | D-0153-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, La Vergne, TN, United States |
| Recall initiated | 2023-10-23 |
| Classified | 2023-12-20 |
| Reported by FDA | 2023-12-27 |
| Terminated | 2024-07-10 |
| Distributed | Nationwide (US) |
| Quantity | 3,718 saleable |
| NDC | 00904-7079-24, 00904-7079-57 |
| Lot numbers | C00079, C00099, C00115 |
| Expiration dates | 2023-12-31, 2024-07-31 |
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 for recall
Failed Content Uniformity Specifications
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-0153-2024. 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.