CLASS I Drug recall · Reported 4 Mar 2020 · FDA Enforcement Report
Phenytoin Oral Suspension USP, 125 mg/ potency recalled
Taro Pharmaceuticals U is recalling Phenytoin Oral Suspension USP, 125 mg/ potency, distributed nationwide in the US. The recall was initiated on 7 Feb 2020 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0863-2020
- FDA event ID
- 84916
- Recalling firm
- Taro Pharmaceuticals U, Hawthorne, NY
- Brand
- Phenytoin
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 7 Feb 2020
- FDA classified
- 2 Mar 2020
- Reported
- 4 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Seizure Medication
Timeline
| 7 Feb 2020 | Recall initiated by company | |
| 2 Mar 2020 | Classified by FDA | +24 days |
| 4 Mar 2020 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the USA.
Questions about this recall
Why was it recalled?
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Which lots are affected?
Lot# 327874, 327876, Exp Dec/2020
Where was it sold?
Distributed Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Taro Pharmaceuticals U
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Hydrocortisone 1% & Acetic Acid 2% Otic Solution recalled | Taro Pharmaceuticals U | Potency & Assay | NY |
| Drug | CLASS III | Clotrimazole and Betamethasone Dipropionate Cream recalledClotrimazole And Betamethasone Dipropionate | Taro Pharmaceuticals U | Potency & Assay | NY |
| Drug | CLASS I | Clobetasol Propionate Ointment USP, 0.05% tubes recalledClobetasol Propionate | Taro Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS II | Nortriptyline HCl Capsules, USP equivalent to 10mg base recalledNortriptyline Hydrochloride | Taro Pharmaceuticals U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | H-e-b - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal recalledHEB | Taro Pharmaceuticals U | Potency & Assay | Nationwide |
Other Phenytoin recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Phenytoin Oral Suspension, USP, 100 mg recalled | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Extended Phenytoin Sodium Capsules, USP, 100 mg recalledExtended Phenytoin Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Extended Phenytoin Sodium Capsules, USP, 100 mg recalledExtended Phenytoin Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | LA, OH, PA |
| Drug | CLASS III | Phenytoin Sodium Injection, USP 100 mg recalledPhenytoin Sodium | Acella Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Phenytoin Sodium Injection, USP, 250 mg recalledPhenytoin Sodium | Acella Pharmaceuticals | Packaging Defects | Nationwide |