Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Consumers and healthcare providers should stop using this product immediately. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. Notification method: Letter
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Diclofenac Sodium, Topical Gel, 3% is a prescription medication used to relieve pain and inflammation. Consumers typically buy it for conditions like arthritis and muscle pain.
The product's viscosity not meeting specifications means it may not deliver the intended therapeutic effects. This could lead to insufficient pain relief for users relying on this medication.
This recall is not part of a broader industry pattern.
Consumers may experience inconvenience due to the need to stop using the product and seek alternatives for pain management.
Lot numbers are typically printed on the side of the tube or on the box packaging.
Expect a refund or replacement process to take 4-6 weeks once the company is contacted.
Keep receipts, lot numbers, and any correspondence with the manufacturer or healthcare provider for your records.
The affected product is Diclofenac Sodium, Topical Gel, 3% in 100 g tubes. It was manufactured by Taro Pharmaceuticals Inc. in Brampton, Ontario, Canada. Lot numbers include AD92720, AD92722, and AD92723, with an expiration date of March 31, 2027.
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