Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Is Trazodone recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Trazodone (9 total). Check the affected lots below.
Most common reason: Labeling / mix-up (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Trazodone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Trazodone recalls in 2026
2 initiated in 2026, 9 in total — newest first
Class II · Moderate risk
Trazodone Hydrochloride
Presence of Foreign Tablets/Capsules
Class III · Low risk
traZODONE Hydrochloride Tablets
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Class II · Moderate risk
Trazodone Hydrochloride Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I · High risk
TraZODONE Hydrochloride Tablets USP 100 mg
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Class II · Moderate risk
Trazodone 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.
Class II · Moderate risk
traZODone HCl Tablet
Labeling: Label Mixup; traZODone HCl Tablet, 150 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 00135051001, Pedigree: AD21858_1, EXP: 5/1/2014; SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: W003256, EXP: 6/17/2014.
Class II · Moderate risk
traZODone HCl Tablet
Labeling: Label Mixup; traZODone HCl Tablet, 50 mg may be potentially mislabeled as AMANTADINE HCL, Tablet, 100 mg, NDC 00832011100, Pedigree: AD54475_1, EXP: 5/20/2014.
Class II · Moderate risk
traZODone HCl Tablet
Labeling: Label Mixup; traZODone HCl Tablet, 50 mg may be potentially mislabeled as DEXAMETHASONE, Tablet, 1 mg, NDC 00054418125, Pedigree: AD37088_1, EXP: 5/9/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD54498_4, EXP: 5/20/2014; guanFACINE HCl, Tablet, 1 mg, NDC 00591044401, Pedigree: AD39611_1, EXP: 4/30/2014.
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