Tadalafil Tablets — Class II drug recall D-0231-2022
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2021-11-17, distributed nationwide. Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
| Recall number | D-0231-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2021-10-25 |
| Classified | 2021-11-12 |
| Reported by FDA | 2021-11-17 |
| Terminated | 2022-09-01 |
| Distributed | Nationwide (US) |
| NDC | 16714-0074, 16714-0074-01, 16714-0074-02, 16714-0075, 16714-0075-01, 16714-0076, 16714-0076-01, 16714-0077, 16714-0077-01 |
| Lot numbers | DNC0814A, DNC0815A |
| Expiration dates | 2023-04 |
Product
Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01
Reason for recall
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
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-0231-2022. 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.