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

Not under an active recall. Efavirenz was recalled 3 times in the past — all now closed. Most recent: Feb 19, 2014.

Most common reason: Labeling / mix-up (2 of these recalls)

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

Efavirenz recalls on record

none so far in 2026; 3 on record, newest first
Class III · Low risk

Atripla

Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.

Terminated Particulate / foreign matter Gilead Sciences, Inc. NDC 15584-0101-1 D-1090-2014
Class II · Moderate risk

Efavirenz

Labeling: Label Mixup: EFAVIRENZ, Tablet, 600 mg may have potentially been mislabeled as the following drug: NIACIN ER, Tablet, 500 mg, NDC 00074307490, Pedigree: AD73637_1, EXP: 5/30/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-801-2014
Class II · Moderate risk

Efavirenz

Labeling: Label Mixup: EFAVIRENZ, Capsule, 200 mg may have potentially been mislabeled as the following drug: metFORMIN HCl, Tablet 500 mg, NDC 23155010201, Pedigree: AD46312_25, EXP: 5/16/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-800-2014