Diclofenac Sodium Topical Solution USP — Class II drug recall D-0941-2023
Ongoing recall by ALEMBIC PHARMACEUTICALS, INC., reported 2023-08-02, distributed nationwide. Defective Delivery System
| Recall number | D-0941-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ALEMBIC PHARMACEUTICALS, INC., Bedminster, NJ, United States |
| Recall initiated | 2023-06-22 |
| Classified | 2023-07-24 |
| Reported by FDA | 2023-08-02 |
| Distributed | Nationwide (US) |
| Quantity | 2,844 units |
| NDC | 62332-0487, 62332-0487-12 |
| Lot numbers | 220151, 220152, 220153 |
| Expiration dates | 2024-11 |
Product
Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12
Reason for recall
Defective Delivery System
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-0941-2023. 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.