Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

Is Entacapone recalled?

Yes — there is an active recall. 1 ongoing FDA recall mention Entacapone (3 total). Check the affected lots below.

Most common reason: Chemical / undeclared (1 of these recalls)

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

Entacapone recalls on record

none so far in 2026; 3 on record, newest first
Class II · Moderate risk

Carbidopa

Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).

Ongoing Labeling / mix-up Rising Pharma Holding, Inc. NDC 16571-691-01 D-0029-2026
Class II · Moderate risk

Stalevo (carbidopa, levodopa, and entacapone)

Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.

Terminated Chemical / undeclared Novartis Pharmaceuticals Corp. NDC 0078-9407-01 D-336-2014