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

Not under an active recall. Quetiapine was recalled 12 times in the past — all now closed. Most recent: Feb 27, 2020.

Most common reason: Labeling / mix-up (8 of these recalls)

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

Quetiapine recalls on record

none so far in 2026; 12 on record, newest first
Class III · Low risk

Quetiapine Fumarate Extended-Release Tablets

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

Terminated Labeling / mix-up The Harvard Drug Group D-1002-2020
Class III · Low risk

Quetiapine Fumarate Extended-Release Tablets

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

Terminated Labeling / mix-up The Harvard Drug Group D-1001-2020
Class III · Low risk

Quetiapine Fumarate Extended-Release Tablets

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

Terminated Labeling / mix-up The Harvard Drug Group D-1000-2020
Class III · Low risk

Quetiapine Fumarate Extended-Release Tablets

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

Terminated Labeling / mix-up The Harvard Drug Group D-0999-2020
Class II · Moderate risk

Quetiapine Fumarate active pharmaceutical ingredient packaged in…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-873-2015
Class II · Moderate risk

QUEtiapine FUMARATE

Labeling:Label Mixup; QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as chlordiazePOXIDE HCl, Capsule, 25 mg, NDC 00555015902, Pedigree: AD49426_1, EXP: 5/16/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-716-2014
Class II · Moderate risk

QUEtiapine FUMARATE Tablet

Labeling:Label Mixup; QUEtiapine FUMARATE Tablet, 100 mg may be potentially mislabeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: W002776, EXP: 6/6/2014; NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: W003823, EXP: 6/27/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD60578_5, EXP: 5/29/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-665-2014
Class II · Moderate risk

QUEtiapine FUMARATE

Labeling:Label Mixup; QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 58914001460, Pedigree: AD32325_1, EXP: 5/9/2014; ASPIRIN DR EC, Tablet, 81 mg, NDC 00182106105, Pedigree: W003094, EXP: 6/13/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-664-2014
Class II · Moderate risk

QUETIAPINE FUMARATE Tablet

Labeling: Label Mixup; QUETIAPINE FUMARATE Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as SIMVASTATIN, Tablet, 40 mg, NDC 00093715598, Pedigree: AD22845_4, EXP: 5/2/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-575-2014
Class II · Moderate risk

QUETIAPINE Fumarate Tablets 25mg 100 Tablets

Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.

Terminated Dissolution failure American Health Packaging NDC 68084-530-01 D-802-2013
Class II · Moderate risk

Dr. Reddy's Quetiapine Fumarate Tablets

Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.

Terminated Dissolution failure Dr. Reddy's Laboratories, Inc. NDC 55111-249-05 D-059-2013