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Class II · ModerateActive recall

Diclofenac Sodium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # AD92721, Exp Date: 3/31/2027.
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySun Pharmaceutical Industries, Inc.
Brand nameDICLOFENAC SODIUM
Generic nameDICLOFENAC SODIUM
Active ingredient(s)DICLOFENAC SODIUM
Distributed by / forSUN PHARMACEUTICAL INDUSTRIES INC
NDC51672-1363-7
Show the full FDA record
Full product labelDiclofenac 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
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionUS Nationwide.
QuantityN/A
Recall initiated2026-01-27
Report date2026-02-11
Recall completed—
Recall numberD-0342-2026
ClassificationClass II
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.