Diclofenac topical gel recalled after failing viscosity specifications
Sun Pharmaceutical Industries is recalling a lot of Diclofenac Sodium Topical Gel, 3%, after an out of specification viscosity result slightly below the limit.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 under the same criterion applied to other out-of-specification results: the record cites a viscosity result slightly below the limit with no stated clinical consequence.
Plain-English summary
Diclofenac Sodium, Topical Gel, 3%, in a 100 g tube, Rx only, manufactured by Taro Pharmaceuticals Inc. of Brampton, Ontario, Canada and distributed by Taro Pharmaceuticals U.S.A., Inc. of Hawthorne, New York, under NDC 51672-1363-7, is being recalled.
The reason given in the enforcement record is failed viscosity specifications: an out of specification result in viscosity for Diclofenac Sodium Gel, 3%, described in the record as slightly lower than the limit.
The record's quantity field reads 'N/A'. The recall covers lot AD92721, expiry 3/31/2027. Distribution was nationwide in the US. The FDA has classified the action as Class II.
Patients should not stop using a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific tube is affected and arrange a replacement.
The recalled product
- Product
- DICLOFENAC SODIUM (DICLOFENAC SODIUM)
- Brand
- DICLOFENAC SODIUM
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Topical NSAID
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # AD92721
- Exp Date: 3/31/2027.
Distribution
Distributed nationwide across the United States.
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