Voltaren Gel — Class III drug recall D-577-2013
Terminated recall by Novartis Consumer Health, reported 2013-06-12, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not
| Recall number | D-577-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Consumer Health, Lincoln, NE, United States |
| Recall initiated | 2013-02-19 |
| Classified | 2013-06-06 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2014-11-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | PA |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00363481684030, 00363481684054 |
| NDC | 63481-0684-47, 63481-0684-83 |
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: 6348168403) and 5/100-g tubes/packs (UPC code: 363481684054 NDC code: 6348168405), Marketed by Endo Pharmaceuticals Inc., Chadds Ford, PA and Manufactured by Novartis Consumer Health, Inc, Parsippany, NJ.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-577-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.