FDA Recall D-0291-2026
Cipla USA, Inc. · Warren, NJ
Class III Ongoing 143 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
Reason for recall
Failed PH Specifications
Recall record
- Recall number
D-0291-2026- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2025-12-22
- Classified by FDA Center
- 2026-01-20
- FDA published
- 2026-01-28
- Recalling firm
- Cipla USA, Inc.
- Firm location
- Warren, NJ
Drug identification
- Brand name(s)
- DICLOFENAC SODIUM
- Generic name(s)
- DICLOFENAC SODIUM
- Manufacturer(s)
- EXELAN PHARMACEUTICALS INC.
- NDC(s)
76282-103- Route(s)
- TOPICAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.