Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Diclofenac recalled?

Yes — there is an active recall. 4 ongoing FDA recalls mention Diclofenac (29 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Diclofenac. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Diclofenac recalls on record

none so far in 2026; 29 on record, newest first
Class III · Low risk

Voltaren Gel

Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.

Terminated Labeling / mix-up Novartis Consumer Health NDC 63481-684-83 D-577-2013
Class II · Moderate risk

Diclofenac Sodium

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1502-2012
Class II · Moderate risk

Arthrotec 75

Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.

Terminated Failed specification Physicians Total Care, Inc. NDC 54868-4165-1 D-1379-2012