Exact FDA event identifier

Event 84916

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: February 07, 2020
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Taro Pharmaceuticals U.S.A., Inc.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0863-2020

Recall number: D-0863-2020
Initiated: February 07, 2020
Classification: Class I
Status: Terminated
Recalling firm: Taro Pharmaceuticals U.S.A., Inc.
Quantity: 29,172 8 Fl Oz bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

Lot# 327874, 327876, Exp Dec/2020

Distribution pattern

Distributed Nationwide in the USA.