FDA Drug recall D-0553-2023
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, Repac…
- FDA Drug
- Class II
- ongoing
- Published 2023-05-03
On 2023-05-03 the FDA classified a Class II recall of 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, Repac… by Northwind Pharmaceuticals, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0553-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-16 |
| Published | 2023-05-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Northwind Pharmaceuticals |
| Distribution | US |
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
CGMP Deviations
Identifiers
| ndc | 51655-473-54 |
|---|---|
| ndc | 51655-473-87 |
| code_info | a) Lot #: F113892002, Exp. Date 08/31/2023; F113892201, Exp. Date 11/30/2023 b) Lot #: F113892001, Exp. Date 08/31/2023…a) Lot #: F113892002, Exp. Date 08/31/2023; F113892201, Exp. Date 11/30/2023 b) Lot #: F113892001, Exp. Date 08/31/2023; F113892202, Exp. Date 11/30/2023; F113892203, Exp. Date 12/31/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0553-2023%22
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