Recall Issued for Diclofenac Sodium Topical Gel Due to pH Specification Failure

Key Takeaways

• The US Food and Drug Administration (FDA) is monitoring a voluntary, firm-initiated Class III recall of diclofenac sodium topical gel, 1%, involving 92 376 tubes distributed nationwide and identified as batch XHBG with an August 31, 2027 expiration date.

• The recall was initiated by Cipla USA, Inc after the product failed to meet pH specifications, a quality issue not expected to cause adverse health consequences.

• Diclofenac sodium topical gel, 1% is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of osteoarthritis-related joint pain, commonly used on the hands and knees.

The FDA has announced a voluntary, firm-initiated recall of Diclofenac Sodium Topical Gel, 1%, packaged in 100 g (3.53 oz) tubes and manufactured by DPT Laboratories, Ltd, San Antonio, Texas. The affected product carries NDC 76282-103-39 and involves 92 376 tubes distributed nationwide in the US. The recall applies specifically to Batch XHBG, with an expiration date of August 31, 2027, and is identified under recall number D-0291-2026 and Event ID 98193.

The FDA has classified this action as a Class III recall, indicating that use of or exposure to the product is not likely to cause adverse health consequences. According to the FDA Enforcement Report, the recall was initiated due to the product failing pH specifications, a quality issue that may affect product performance or stability but is not expected to pose a significant safety risk. The recall remains ongoing, and no press release has been issued at this time. Initial notification to consignees was made by letter, and the FDA assigned the center classification date of January 20, 2026, following the recall initiation on December 22, 2025.

The recalling firm is Cipla USA, Inc, headquartered in Warren, New Jersey. Cipla initiated the recall voluntarily and is coordinating with distributors and downstream partners to remove the affected lot from the supply chain. Pharmacists should review inventory for the specified batch and expiration date, quarantine affected units, and follow Cipla’s instructions for disposition. At this time, the FDA has not reported adverse events associated with this recall.

Diclofenac sodium topical Gel, 1% is a NSAID indicated for the relief of pain associated with osteoarthritis of joints amenable to topical treatment, such as the knees and hands. It works by inhibiting cyclooxygenase enzymes, thereby reducing inflammation and pain at the site of application.