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

Not under an active recall. Venlafaxine was recalled 29 times in the past — all now closed. Most recent: Mar 21, 2025.

Most common reason: Dissolution failure (12 of these recalls)

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

Venlafaxine recalls on record

none so far in 2026; 29 on record, newest first
Class II · Moderate risk

Venlafaxine Tablets

Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.

Completed Particulate / foreign matter Zydus Pharmaceuticals (USA) Inc NDC 68382-021-01 D-0310-2025
Class II · Moderate risk

Venlafaxine Hydrochloride

Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.

Terminated Dissolution failure The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7075-61 D-0584-2024
Class II · Moderate risk

Venlafaxine Tablets

Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg

Terminated Labeling / mix-up Sun Pharmaceutical Industries INC NDC 16714-657-01 D-0703-2021
Class II · Moderate risk

Venlafaxine HCL ER Capsule USP

Failed Dissolution Specifications: out of specification dissolution results in retained samples

Terminated Dissolution failure Zydus Pharmaceuticals USA Inc NDC 68382-035-06 D-1461-2016
Class II · Moderate risk

Venlafaxine HCL ER Capsule USP

Failed Dissolution Specifications: out of specification dissolution results in retained samples

Terminated Dissolution failure Zydus Pharmaceuticals USA Inc NDC 68382-036-06 D-1460-2016
Class III · Low risk

Venlafaxine 75 mg Tablet

Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.

Terminated Labeling / mix-up Bryant Ranch Prepack Inc. NDC 63629-3324-6 D-0837-2016
Class II · Moderate risk

Venlafaxine HCl 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-952-2015
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 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 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 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

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