Tadalafil Tablets — Class II drug recall D-0553-2023
Ongoing recall by Northwind Pharmaceuticals LLC, reported 2023-05-03, distributed nationwide. CGMP Deviations
| Recall number | D-0553-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Northwind Pharmaceuticals LLC, Indianapolis, IN, United States |
| Recall initiated | 2023-03-16 |
| Classified | 2023-04-26 |
| Reported by FDA | 2023-05-03 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 51655-0473, 51655-0473-54, 51655-0473-87 |
| Lot numbers | F113892001, F113892002, F113892201, F113892202, F113892203 |
| Expiration dates | 2023-08-31, 2023-11-30, 2023-12-31 |
Product
Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Reason for recall
CGMP Deviations
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-0553-2023. 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.