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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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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