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

Not under an active recall. Melatonin was recalled 14 times in the past — all now closed. Most recent: Jan 24, 2022.

Most common reason: cGMP deviation (7 of these recalls)

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

Melatonin recalls on record

none so far in 2026; 14 on record, newest first
Class II · Moderate risk

Melatonin

Labeling:Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W003711, EXP: 6/26/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-734-2014
Class II · Moderate risk

MELATONIN Tablet

Labeling: Label Mixup; MELATONIN Tablet, 3 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD25452_13, EXP: 5/3/2014; PIOGLITAZONE, Tablet, 15 mg, NDC 00591320530, Pedigree: AD28322_4, EXP: 4/30/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD70655_11, EXP: 5/28/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree

Terminated Labeling / mix-up Aidapak Services, LLC D-605-2014
Class II · Moderate risk

MELATONIN Tablet

Labeling: Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: AD46265_28, EXP: 5/15/2014; GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg, NDC 00904559293, Pedigree: AD60211_17, EXP: 5/22/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-576-2014
Class II · Moderate risk

MELATONIN Tablet

Labeling: Label Mixup; MELATONIN Tablet, 1 mg may be potentially mislabeled as CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W002692, EXP: 6/5/2014; GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: W003252, EXP: 6/17/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-547-2014
Class II · Moderate risk

Melatonin

Labeling: Label Mixup; MELATONIN, Tablet, 3 mg may be potentially mislabeled as VITAMIN B COMPLEX, Capsule, NDC 00536478701, Pedigree: AD32757_4, EXP: 5/13/2014; MULTIVITAMIN/ MULTIMINERAL/ LUTEIN, Capsule, NDC 24208063210, Pedigree: W003025, EXP: 6/12/2014; LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: W003721, EXP: 6/26/2014; GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400

Terminated Labeling / mix-up Aidapak Services, LLC D-497-2014
Class II · Moderate risk

Melatonin

Labeling: Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as QUETIAPINE FUMARATE, Tablet, 12.5 MG (1/2 of 25 MG), NDC 47335090288, Pedigree: AD21790_79, EXP: 5/1/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD73521_13, EXP: 5/30/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-494-2014