Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Mental Health Medication Recalls

Recalls of antidepressants, anti-anxiety and related psychiatric medications.

224 recalls in this category, newest first.

Class I · High risk

Venlafaxine HCl Extended-Release Capsules

Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule was found in a bottle of Effexor XR (venlafaxine HCl) 150 mg capsules that was packaged in the same packaging campaign as the recalled lot

Terminated Particulate / foreign matter Greenstone Llc NDC 59762-0182-2 D-1361-2014
Class I · High risk

Effexor XR

Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.

Terminated Particulate / foreign matter Pfizer Us Pharmaceutical Group NDC 0008-0836-21 D-1328-2014
Class II · Moderate risk

Duloxetine Delayed-Release Capsules

Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.

Terminated Failed specification Teva Pharmaceuticals USA NDC 0093-7544-56 D-1184-2014
Class II · Moderate risk

Duloxetine Delayed-Release Capsules

Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.

Terminated Failed specification Teva Pharmaceuticals USA NDC 0093-7543-56 D-1183-2014
Class II · Moderate risk

Duloxetine Delayed-Release Capsules

Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.

Terminated Failed specification Teva Pharmaceuticals USA NDC 0093-7542-06 D-1182-2014
Class III · Low risk

Venlafaxine Hydrochloride

Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.

Terminated Dissolution failure McKesson Packaging Services NDC 63739-0512-10 D-1167-2014
Class II · Moderate risk

Fluoxetine Capsules

Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.

Terminated Chemical / undeclared Legacy Pharmaceutical Packaging NDC 68645-130-54 D-1279-2014
Class II · Moderate risk

Fluoxetine Capsules USP

Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.

Terminated Chemical / undeclared Teva Pharmaceuticals USA NDC 50111-647-01 D-1281-2014
Class II · Moderate risk

Fluoxetine Capsules USP

Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.

Terminated Chemical / undeclared Teva Pharmaceuticals USA NDC 50111-648-01 D-1280-2014
Class II · Moderate risk

Alprazolam 1 mg Tablets

Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.

Terminated Failed specification Actavis Elizabeth LLC NDC 0228-2031-50 D-1153-2014
Class II · Moderate risk

Clonazepam Tablets

Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.

Terminated Wrong potency / content Actavis Elizabeth LLC NDC 0228-3005-11 D-1087-2014
Class II · Moderate risk

sertraline HCl tablets

Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36 month shelf life, instead of the 24 month shelf life

Terminated Labeling / mix-up Greenstone LLC NDC 59762-4960-1 D-746-2014
Class III · Low risk

Venlafaxine

Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.

Terminated Dissolution failure Osmotica Pharmaceutical Corp NDC 0131-3268-32 D-1067-2013
Class III · Low risk

buPROPion Hydrochloride Extended-Release Tablets

Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.

Terminated Dissolution failure Actavis South Atlantic LLC NDC 67767-142-30 D-917-2013
Class II · Moderate risk

Venlafaxine HCL ER

Labeling: Label Mixup: VENLAFAXINE HCL ER, Capsule, 150 mg may have potentially been mislabeled as one of the following drugs: SOTALOL HCL, Tablet, 80 mg, NDC 00093106101, Pedigree: AD30993_17, EXP: 5/9/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: W003075, EXP: 6/12/2014; LANTHANUM CARBONATE, CHEW Tablet, 500 mg, NDC 4092025290, Pedigree: W003410, EXP: 6/19/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-848-2014
Class II · Moderate risk

Venlafaxine HCL

Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 100 mg may have potentially was mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD73525_31, EXP: 5/30/2014; and may have potentially been mislabeled as one of the following drugs: methylPREDNISolone, Tablet, 4 mg, NDC 00603459321, Pedigree: AD32764_11, EXP: 3/31/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree:

Terminated Labeling / mix-up Aidapak Services, LLC D-847-2014
Class II · Moderate risk

Venlafaxine HCL

Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 75 mg may have potentially been mislabeled as the following drug: TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: W002508, EXP: 6/3/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-846-2014
Class II · Moderate risk

Escitalopram

Labeling: Label Mixup: ESCITALOPRAM, Tablet, 5 mgmay have potentially been mislabeled as the following drug: SODIUM CHLORIDE, Tablet, 1 gm, NDC 00223176001, Pedigree: W003707, EXP: 6/25/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-839-2014
Class II · Moderate risk

clonazePAM

Labeling: Label Mixup: clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg) may have potentially been mislabeled as the following drug: CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: ADWA00002136, EXP: 5/31/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-830-2014
Class II · Moderate risk

Venlafaxine HCL

Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 25 mg may have potentially been mislabeled as one of the following drugs: sitaGLIPtin PHOSPHATE, Tablet, 50 mg, NDC 00006011231, Pedigree: W002824, EXP: 6/7/2014; LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: W003847, EXP: 6/27/2014; LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD62796_1, EXP: 5/22/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-822-2014
Class II · Moderate risk

DULoxetine HCl DR

Labeling: Label Mixup: DULoxetine HCl DR, Capsule, 20 mg, may be potentially mis-labeled with one of the following drugs: ENTECAVIR, Tablet, 0.5 mg, NDC 00003161112, Pedigree: AD30140_28, EXP: 5/7/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD54587_1, EXP: 5/21/2014; FLUoxetine HCl, Capsule, 10 mg , NDC 16714035103, Pedigree: AD70585_13, EXP: 5/29/2014; CHOLECALCIFEROL

Terminated Labeling / mix-up Aidapak Services, LLC D-766-2014