Exact FDA event identifier

Event 97944

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

Open FDA event record

Event summary

Timeline bucket: November 07, 2025
Product types: Drug
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: Teva Pharmaceuticals 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

Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.

D-0198-2026

Recall number: D-0198-2026
Initiated: November 07, 2025
Classification: Class III
Status: Ongoing
Recalling firm: Teva Pharmaceuticals USA, Inc
Quantity: 15,944 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective Container - A defect in the side-seal which allows leakage of product.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container - A defect in the side-seal which allows leakage of product.

Code information

Lot #100068692, Exp.: 04/30/2027

Distribution pattern

U.S. Nationwide