Lower risk Drug recall · FDA · Published February 7, 2020

Taro Pharmaceuticals Phenytoin Oral Suspension Recall: Resuspension Issues

Taro Pharmaceuticals recalls Phenytoin Oral Suspension USP 125mg/5mL due to potential coagulation and failure to resuspend as per label instructions. Affected lots may not mix properly after shaking.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0863-2020Drug Taro Pharmaceuticals ›

Lower-risk recall

Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.

Take action

Contact the company

Recalling firmTaro Pharmaceuticals U.S.A., Inc.3 Skyline Dr · Hawthorne, NY 10532-2174

✎ GovInfoNow plain-language explainer

Taro Pharmaceuticals is recalling Phenytoin Oral Suspension USP 125mg/5m: 8 fl oz bottles that may coagulate and not resuspend properly after shaking. This could lead to inconsistent dosing if the medication doesn't mix correctly. Read more at govinfonow.com/recall/37377-taro-pharmaceuticals-phenytoin-oral-suspension-recall-resuspension-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/37377-taro-pharmaceuticals-phenytoin-oral-suspension-recall-resuspension-issues · Updated October 5, 2026 · FDA enforcement record: FDA #D-0863-2020

Cite this page

“Taro Pharmaceuticals Phenytoin Oral Suspension Recall: Resuspension Issues.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37377-taro-pharmaceuticals-phenytoin-oral-suspension-recall-resuspension-issues. Based on FDA recall #D-0863-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0863-2020%22&limit=1).

The FDA announced on Feb. 7, 2020, that Taro Pharmaceuticals U.S.A., Inc. voluntarily recalled Phenytoin Oral Suspension USP due to resuspension problems. Two lots of the drug may coagulate and fail to resuspend as labeled. Owners should contact the company for a refund.

How to tell if you have it

Brand: Taro Pharmaceuticals
Product: Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL)
NDC: 51672-4069-1
Lot codes: 327874, 327876
Distribution: Nationwide in the USA

The hazard

Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions. This defect poses a risk of incorrect dosing.

Context

GovInfoNow's records show Taro Pharmaceuticals U.S.A., Inc. has 20 other recalls on record since 2012-11-21. Other recent recalls include Taro Hydrocortisone Otic Solution (2024-08-07), Taro Clotrimazole-Betamethasone (2022-02-25), and Taro Clobetasol Ointment (2021-12-15). Similar recent recalls of other brands include AvKARE Rosuvastatin Tablets (2025-12-31) and Alvogen Thyro-Tabs (2025-12-31).

How to tell if you have this one

Check for the product name 'Phenytoin Oral Suspension USP 125mg/5mL', 8 fl oz (237 mL) bottle. Affected lots are 327874 and 327876, manufactured by Taro Pharmaceuticals Industries Ltd. in Haifa, Israel.

Brand
Taro Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for the lot numbers 327874 or 327876 on the bottle label.
Contact Your Pharmacist
Ask your pharmacist for a replacement or alternative medication if you have the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Distributed Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.8 years after the firm started it.

Feb 7, 2020Firm started the recall
Mar 2, 2020FDA classified it Class I
Mar 4, 2020Published in FDA’s Enforcement Report
Dec 11, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/37377-taro-pharmaceuticals-phenytoin-oral-suspension-recall-resuspension-issues">Taro Pharmaceuticals Phenytoin Oral Suspension Recall: Resuspension Issues (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0863-2020 (February 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0863-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.