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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Topical Products

Diclofenac Sodium Topical Gel Recalled for Failed Viscosity

Agency Publication Date: February 5, 2026
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Summary

Sun Pharmaceutical Industries Inc. is recalling one lot of Diclofenac Sodium (3%) Topical Gel, a prescription nonsteroidal anti-inflammatory drug (NSAID) used for skin conditions. The recall was initiated because the product's thickness (viscosity) was slightly lower than the required limit, which may affect how the gel is applied or absorbed. This recall affects a 100-gram tube manufactured by Taro Pharmaceuticals in Canada and distributed nationwide across the United States.

Risk

A lower-than-expected viscosity can cause the medication to be thinner than intended, potentially leading to inconsistent dosing or difficulty applying the correct amount of the gel to the skin.

What You Should Do

  1. Check your medication for Diclofenac Sodium, Topical Gel, 3% in a 100 g tube with NDC 51672-1363-7.
  2. Locate the lot number and expiration date on the tube; this recall specifically affects Lot # AD92721 with an expiration date of 3/31/2027.
  3. 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 Sun Pharmaceutical Industries Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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 Gel, 3% (100 g tube)by Taro Pharmaceuticals
Variants: Rx only
Lot Numbers:
AD92721 (Exp 3/31/2027)
NDC:
51672-1363-7

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada; Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98351
Status: Active
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: Pharmacies
Manufactured In: Canada, United States
Distributed To: Nationwide
Agency Last Updated: February 23, 2026

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 ยท 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.