Recalls / Class III
Class IIID-0291-2026
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
- Brand name
- Diclofenac Sodium
- Generic name
- Diclofenac Sodium
- Active ingredient
- Diclofenac Sodium
- Route
- Topical
- NDC
- 76282-103
- FDA application
- ANDA209903
- Affected lot / code info
- Batch XHBG; Exp. 08/31/2027
Why it was recalled
Failed PH Specifications
Recalling firm
- Firm
- Cipla USA, Inc.
- Manufacturer
- EXELAN PHARMACEUTICALS INC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Independence Blvd, Warren, New Jersey 07059-2730
Distribution
- Quantity
- 92,376 tubes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-12-22
- FDA classified
- 2026-01-20
- Posted by FDA
- 2026-01-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0291-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.