The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0168-2021·Announced 2020-12-23

AvKare Recalls Trazodone Hydrochloride Tablets Due to Sildenafil Packaging Mix-Up

AvKare Inc. is recalling 14,368 bottles of Trazodone Hydrochloride Tablets 100 mg because they were inadvertently packaged with sildenafil.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score due to the potential for serious adverse health consequences.

Plain-English summary

AvKare Inc. is recalling 14,368 bottles of Trazodone Hydrochloride Tablets USP 100 mg (NDC 42291-834-10). The affected product is Lot 36783 with an expiration date of 06/2022. The recall is due to a product mix-up where bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a third-party facility.

The recalled product was distributed nationwide within the U.S. This recall is classified as FDA Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.

Consumers should stop using the affected trazodone tablets and contact their healthcare provider or pharmacist for guidance. Patients should verify their medication to ensure they are not taking sildenafil instead of trazodone.

The recalled product

Product
TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10
Manufacturer
AVKARE Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
14,368

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: 36783 Exp. 06/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by AVKARE Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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