FDA Drug recall D-0863-2020
Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd
- FDA Drug
- Class I
- terminated
- Published 2020-03-04
On 2020-03-04 the FDA classified a Class I recall of Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd by Taro Pharmaceuticals U, citing resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0863-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-02-07 |
| Published | 2020-03-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Taro Pharmaceuticals U |
| Distribution | US |
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
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Identifiers
| ndc | 51672-4069-1 |
|---|---|
| ndc | 51672-4069-2 |
| code_info | Lot# 327874, 327876, Exp Dec/2020 |
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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All Taro Pharmaceuticals U recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0863-2020%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.