Exact FDA event identifier

Event 98193

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

Event summary

Timeline bucket: December 22, 2025
Product types: Drug
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: Cipla USA, 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

Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39

D-0291-2026

Recall number: D-0291-2026
Initiated: December 22, 2025
Classification: Class III
Status: Ongoing
Recalling firm: Cipla USA, Inc.
Quantity: 92,376 tubes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Failed PH Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed PH Specifications

Code information

Batch XHBG; Exp. 08/31/2027

Distribution pattern

Nationwide in the USA