Diclofenac Sodium — Class II drug recall D-0342-2026
Ongoing recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2026-02-11, distributed nationwide. Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosit
| Recall number | D-0342-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2026-01-27 |
| Classified | 2026-02-23 |
| Reported by FDA | 2026-02-11 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 51672-1363, 51672-1363-03, 51672-1363-07 |
| Lot numbers | AD92721 |
| Expiration dates | 2027-03-31 |
Product
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7
Reason for recall
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
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-0342-2026. 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.