CLASS II Drug recall · Reported 23 Dec 2020 · FDA Enforcement Report

Sildenafil Tablets USP 100 mg recalled by AVKARE

Avkare is recalling Sildenafil Tablets USP 100 mg, distributed nationwide in the US. The recall was initiated on 7 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 36884 Exp. 03/2022

Quantity recalled38715 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0167-2021
FDA event ID: 86940
Recalling firm: Avkare, Pulaski, TN
Classification: Class II
Status: Terminated
Recall initiated: 7 Dec 2020
FDA classified: 16 Dec 2020
Reported: 23 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Hidden Drug Ingredients

Timeline

7 Dec 2020	Recall initiated by company
16 Dec 2020	Classified by FDA	+9 days
23 Dec 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.

Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.

Product as listed by the FDA

Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.

Where it was distributed

Nationwide within the U.S.

Nationwide

Questions about this recall

Why was it recalled?

Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.

Which lots are affected?

Lot: 36884 Exp. 03/2022

Where was it sold?

Nationwide within the U.S.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 86940

This product is part of a recall event; the main page for the event is TraZODONE Hydrochloride Tablets USP 100 mg recalled by AVKARE.

Reported	Class	Recall	Company	Reason	Where
23 Dec 2020	CLASS I	TraZODONE Hydrochloride Tablets USP 100 mg recalled by AVKARE	Avkare	Hidden Drug Ingredients	Nationwide

More recalls from Avkare

All 62

Reported	Class	Recall	Company	Reason	Where
4 Mar 2026Drug	CLASS II	Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl	AvKARE	Potency & Assay	Nationwide
14 Jan 2026Drug	CLASS II	Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin	AvKARE	Potency & Assay	Nationwide
15 Oct 2025Drug	CLASS II	Norgestimate and Ethinyl Estradiol Tablets recalled by AvKARENorgestimate And Ethinyl Estradiol	AvKARE	Other	Nationwide
17 Sep 2025Drug	CLASS II	chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride	AvKARE	Other	Nationwide
17 Sep 2025Drug	CLASS II	chloroproMAZINE Hydrochloride Tablets, USP, 50 mg unit dose recalledChlorpromazine Hydrochloride	AvKARE	Other	Nationwide

Other Sildenafil recalls

All 6

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Drug	CLASS II	Sildenafil Citrate recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem	Manufacturing (CGMP) Deviations	Nationwide
19 Aug 2026Drug	CLASS II	Sildenafil Citrate USP, 100 gm recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem	Manufacturing (CGMP) Deviations	Nationwide
5 Feb 2020Drug	CLASS II	Sildenafil 80 mg capsules recalled by MPRX	Mprx	Hidden Drug Ingredients	TX
20 May 2015Drug	CLASS II	Sildenafil 10 mg/ Susp, Health Innov Pharmacy recalled	Health Innovations Pharmacy	Sterility	NC
29 Jan 2014Drug	CLASS II	Sildenafil Citrate, Tablet, 25 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states