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Recall Observatory FDA recall evidence

Drug product

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

December 22, 2025

Class III

Product summary

Firm
Cipla USA, Inc.
Event
Event 98193
Status
Ongoing
Classification
Class III
Quantity
92,376 tubes
Official record key
drug-enforcement:D-0291-2026

Official wording

Reason: Failed PH Specifications

Code information: Batch XHBG; Exp. 08/31/2027

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed PH Specifications