Sildenafil Tablets USP 100 mg — Class II drug recall D-0167-2021
Terminated recall by AVKARE Inc., reported 2020-12-23, distributed nationwide. Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a
| Recall number | D-0167-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2020-12-07 |
| Classified | 2020-12-16 |
| Reported by FDA | 2020-12-23 |
| Terminated | 2023-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 38,715 bottles |
| NDC | 42291-0748-01 |
| Lot numbers | 36884 |
| Expiration dates | 2022-03 |
Product
Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.
Reason for recall
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0167-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.