Phenytoin Oral Suspension USP — Class I drug recall D-0863-2020
Terminated recall by Taro Pharmaceuticals U.S.A., Inc., reported 2020-03-04, distributed nationwide. Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend
| Recall number | D-0863-2020 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, United States |
| Recall initiated | 2020-02-07 |
| Classified | 2020-03-02 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2023-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 29,172 |
| Reason classes | labeling |
| NDC | 51672-4069, 51672-4069-01, 51672-4069-02 |
| Lot numbers | 327874, 327876, DEC/2020 |
Product
Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532, NDC 51672-4069-1
Reason for recall
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
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-0863-2020. 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.