Medications & Supplements/Topical Products

Diclofenac Sodium Topical Solution Recalled for Defective Delivery System

Agency Publication Date: July 24, 2023

Summary

Alembic Pharmaceuticals, Inc. is recalling 2,844 units of Diclofenac Sodium Topical Solution USP, 2% w/w. This prescription medication, which is used to treat pain, is being recalled because the bottle's delivery system is defective. If you have this product, you should contact your healthcare provider or pharmacist for guidance regarding your treatment.

Risk

A defective delivery system can prevent the medication from being dispensed correctly, which may result in an inaccurate dose or an inability to access the treatment.

What You Should Do

This recall affects Diclofenac Sodium Topical Solution USP, 2% w/w, sold in 3.8 FL.OZ. (112 gram) bottles with NDC 62332-487-12.
Identify your product by checking the lot numbers and expiration dates printed on the packaging: lot numbers 220151, 220152, and 220153 with an expiration date of 11/2024 are included in this recall.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Alembic Pharmaceuticals, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Diclofenac Sodium Topical Solution USP, 2% w/w (3.8 FL.OZ. / 112 grams)

Variants: Topical Solution, 2% w/w, 3.8 FL.OZ. (112 grams)

Lot Numbers:

220151 (Exp. 11/2024)

220152 (Exp. 11/2024)

220153 (Exp. 11/2024)

NDC:

62332-487-12

Manufactured for Alembic Pharmaceuticals, Inc. Bedminster, NJ. Manufactured by Alembic Pharmaceuticals Limited (Derma Division) India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92581

Status: Active

Manufacturer: ALEMBIC PHARMACEUTICALS, INC.

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 2844 units

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Diclofenac Sodium Topical Solution USP, 2% w/w, sold in 3.8 FL.OZ. (112 gram) bottles with NDC 62332-487-12.

Identify your product by checking the lot numbers and expiration dates printed on the packaging: lot numbers 220151, 220152, and 220153 with an expiration date of 11/2024 are included in this recall.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Alembic Pharmaceuticals, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Diclofenac Sodium Topical Solution USP, 2% w/w (3.8 FL.OZ. / 112 grams)

Variants: Topical Solution, 2% w/w, 3.8 FL.OZ. (112 grams)

Lot Numbers:

220151 (Exp. 11/2024)

220152 (Exp. 11/2024)

220153 (Exp. 11/2024)

NDC:

62332-487-12

Manufactured for Alembic Pharmaceuticals, Inc. Bedminster, NJ. Manufactured by Alembic Pharmaceuticals Limited (Derma Division) India.