Recall Weekly
Moderate riskFDA DrugClass II

Sun Pharmaceutical diclofenac gel recalled for viscosity failure

Sun Pharmaceutical is recalling one lot of Diclofenac Sodium Topical Gel, 3% (Lot #AD92721, expiring 3/31/2027) because the gel's thickness is slightly lower than required specifications. The product was distributed nationwide and is sold by prescription only.

From the FDA notice · Read the official notice ↗ · All Sun Pharmaceutical recalls

What to do

  1. Check your Diclofenac Sodium Gel 3% tube for Lot #AD92721
  2. Stop using this lot and do not apply it to your skin
  3. Contact your pharmacy or doctor for a replacement or alternative pain relief medication
  4. Do not throw the gel in the trash; ask your pharmacy how to dispose of it safely
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Diclofenac 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
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Units affected
N/A
Illnesses reported
None reported
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Classification
Class II
Recall number
D-0342-2026

In the FDA's words

Description
Diclofenac 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 Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. Lot # AD92721, Exp Date: 3/31/2027. Distribution: US Nationwide. Affected quantity: N/A
Hazard
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

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