Food, drugs, devices › AVKARE Inc.
Drug recall: Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.
AVKARE Inc. (Pulaski, TN) initiated this drug recall on 7 Dec 2020; FDA lists 2 product records under event 86940, classified Class I.
FDA defines Class I as 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. 15% of the 342 drug enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 16 Oct 2023. Initiation: voluntary: firm initiated. AVKARE Inc. has 22 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
AVKARE Inc., Pulaski, TN.
Reason for recall
"Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility."
Distribution
"Nationwide within the U.S."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0167-2021 | Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01. | 38715 bottles | Class II | Terminated | 23 Dec 2020 |
| D-0168-2021 | TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10 | 14368 bottles | Class I | Terminated | 23 Dec 2020 |
Context
Other enforcement events for AVKARE Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within the U.S."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Oct 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.