Lower riskDrug recall · FDA · Published December 7, 2020
AVKARE TraZODONE 100mg Tablets Recall: Mix-up with Sildenafil Risk
AVKARE recalls 1000-count TraZODONE Hydrochloride Tablets due to accidental packaging mix-up with sildenafil. Consumers should check product details and contact for safety.
“AVKARE TraZODONE 100mg Tablets Recall: Mix-up with Sildenafil Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36626-avkare-trazodone-100mg-tablets-recall-mix-up-with-sildenafil-risk. Based on FDA recall #D-0168-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0168-2021%22&limit=1).
The FDA announced on 2020-12-07 that AVKARE Inc. voluntarily recalled TraZODONE Hydrochloride Tablets USP 100 mg due to a product mix-up hazard where sildenafil was inadvertently packaged with trazodone. Owners should contact the company for a refund.
The product mix-up occurred when bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a third-party facility, according to the FDA. This Class I recall involves 14,368 bottles distributed nationwide within the U.S.
Context
GovInfoNow's records show AVKARE Inc. has 21 other recalls on record since 2015-02-27. Other recent recalls of similar products include AvKare Recalls Lamotrigine 100mg Due to Label Error (2022-07-20), AVKARE Phytonadione Tablets 5mg Recall: Impurity Risk (2021-06-09), and AVKARE Mesalamine Tablets Recall: Failed Dissolution Specifications (2020-10-30). Other recent recalls of similar products include Granules Pharmaceuticals Trazodone 50mg Recall: Foreign Tablets Found (2026-01-26), Teva recalls traZODone 50mg tablets with foreign tablets risk (2026-08-24), and Annora Pharma Lacosamide Tablets Recall: Possible Selexipag Mix-Up (2026-06-04).
How to tell if you have this one
Check for the product name 'TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle' with NDC 42291-834-10 and lot number 36783 (expiring June 2022).
Brand
AVKARE
Category
Drug
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0168-2021 (December 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0168-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.