Medications & Supplements/Topical Products

Diclofenac Sodium Topical Gel Recalled for Failed pH Specifications

Agency Publication Date: January 20, 2026

Summary

Cipla USA, Inc. has voluntarily recalled 92,376 tubes of Diclofenac Sodium Topical Gel, 1% (generic Voltaren), which is used for treating arthritis pain. The recall was initiated because the product failed to meet specific pH requirements, which can affect the drug's stability or effectiveness. This medication was distributed nationwide across the United States in 100-gram (3.53-ounce) tubes.

Risk

The product does not meet internal chemical specifications for pH levels, which may impact how the medication performs or its shelf-life stability.

What You Should Do

Check your product packaging for Diclofenac Sodium Topical Gel, 1% in the 100 g (3.53 oz) size with NDC 76282-103-39.
Locate the batch code XHBG and expiration date 08/31/2027 printed on the tube or carton to confirm if your medication is affected.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Diclofenac Sodium Topical Gel, 1% (100 g / 3.53 oz)

Variants: Topical Gel, 1%

Lot Numbers:

XHBG (Exp. 08/31/2027)

NDC:

76282-103-39

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98193

Status: Active

Manufacturer: Cipla USA, Inc.

Sold By: Retail pharmacies

Manufactured In: United States

Units Affected: 92,376 tubes

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your product packaging for Diclofenac Sodium Topical Gel, 1% in the 100 g (3.53 oz) size with NDC 76282-103-39.

Locate the batch code XHBG and expiration date 08/31/2027 printed on the tube or carton to confirm if your medication is affected.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.