FDA Drug recall D-0231-2022
Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmace…
- FDA Drug
- Class II
- terminated
- Published 2021-11-17
On 2021-11-17 the FDA classified a Class II recall of Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmace… by Sun Pharmaceutical Industries, citing incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0231-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-25 |
| Published | 2021-11-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Identifiers
| ndc | 16714-074-01 |
|---|---|
| ndc | 16714-074-02 |
| ndc | 16714-075-01 |
| ndc | 16714-076-01 |
| ndc | 16714-077-01 |
| code_info | Lot # DNC0814A, DNC0815A, Exp. Date 04/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0231-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.