Novartis Recalls Voltaren Gel Due to Illegible Lot and Expiration Dates
Novartis Consumer Health is recalling Voltaren Gel because lot and expiration dates on the tubes may be illegible. The FDA classifies this as a Class III recall.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classifies this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard is limited to documentation and labeling issues (illegible dates) rather than a direct safety risk like contamination or injury.
Plain-English summary
Novartis Consumer Health is recalling specific lots of Voltaren Gel (diclofenac sodium topical gel) 1% due to labeling issues. The lot and/or expiration dates on the affected tubes may not be legible, making it difficult for patients and healthcare providers to verify the product's identity and shelf life.
The recall covers 20-gm and 100-gm tubes, including physician samples and multi-packs. The affected products were distributed nationwide, in Puerto Rico, and in Panama, with military distribution also made. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should check the lot and expiration dates on their Voltaren Gel tubes against the list of affected lots provided by the manufacturer. If the dates are illegible or match the recalled lots, the product should be returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g tubes are also packaged 3/100-g tubes/packs (UPC code: 363481684030 NDC code: 6
- Manufacturer
- Novartis Consumer Health
- Category
- Drug — Topical Analgesic
- Hazard
Distribution
Part of a larger recall action
This product is one of 5 recalled by Novartis Consumer Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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