Prescription Diclofenac Sodium Topical Gel Recalled for Viscosity Specification Failure
SUN PHARMACEUTICAL is recalling Diclofenac Sodium Topical Gel (3% in 100 g tubes) due to viscosity specification failure. Lot AD92721 (expires 3/31/2027) was distributed nationwide.
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: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is a manufacturing specification deficiency without high-risk characteristics such as allergen mislabeling or pathogenic contamination.
Plain-English summary
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Diclofenac Sodium Topical Gel, 3% strength in 100 g tubes (NDC 51672-1363-7), manufactured by Taro Pharmaceuticals Inc. and distributed by Taro Pharmaceuticals U.S.A., Inc.
The product failed to meet viscosity specifications. Testing found viscosity results slightly lower than the established limit, indicating a manufacturing control issue.
The affected product is lot number AD92721 with an expiration date of March 31, 2027. It was distributed nationwide. Consumers who have this product should consult with their healthcare provider or pharmacist. This is a prescription medication.
The recalled product
- Product
- DICLOFENAC SODIUM (DICLOFENAC SODIUM)
- Brand
- DICLOFENAC SODIUM
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- Hazard
- viscosity-specification-failure
- manufacturing-defect
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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