Why it was recalled
Failed PH Specifications
Product description
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
Lot numbers, UPCs & expiration codes
Batch XHBG; Exp. 08/31/2027
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0291-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Dec 22, 2025
- FDA report date
- Jan 28, 2026
- Quantity
- 92,376 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cipla USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0291-2026, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98193
- Address
- 10 Independence Blvd
- Code information
- Batch XHBG; Exp. 08/31/2027
- Postal code
- 07059-2730
- Report date
- Jan 28, 2026
- Product type
- Drugs
- Recall number
- D-0291-2026
- Classification
- Class III
- Recalling firm
- Cipla USA, Inc.
- Product quantity
- 92,376 tubes
- Reason for recall
- Failed PH Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 22, 2025
- Initial firm notification
- Letter
- Center classification date
- Jan 20, 2026