Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Diclofenac Sodium Topical Solution USP Recalled by ALEMBIC PHARMACEUTICALS, INC. Due to Defective Delivery System

Date: June 22, 2023
Company: ALEMBIC PHARMACEUTICALS, INC.
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ALEMBIC PHARMACEUTICALS, INC. directly.

Affected Products

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

Quantity: 2844 units

Why Was This Recalled?

Defective Delivery System

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ALEMBIC PHARMACEUTICALS, INC.

ALEMBIC PHARMACEUTICALS, INC. has 2 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report