---
title: "Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 1... — FDA record D-0417-2023 | Is It on Recall"
description: "CGMP Deviations: recalling drug products following an FDA inspection."
url: https://isitonrecall.com/recall/fda-drug-d-0417-2023-tadalafil-tablets-usp-20-mg-rx-only-packaged-as-a-30-count-bottle-ndc-16729-372-10-upc-3-16729-37210/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500... — FDA record D-0417-2023

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 7, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-count bottle NDC 16729-372-16, UPC 3 16729 37216 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- **Reason**: CGMP Deviations: recalling drug products following an FDA inspection.
- **Classification**: Class II
- **Recalling firm**: Accord Healthcare, Inc.
- **Quantity**: 613,553 bottles
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0417-2023

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0417-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Batches: a) P2002461, Exp. Date 4/30/2023; P2002457, Exp. Date 4/30/2023; P2002460, Exp. Date 4/30/2023; P2002464, Exp. Date 4/30/2023; P2002463, Exp. Date 4/30/2023; P2002462, Exp. Date 4/30/2023; P2002465, Exp. Date 4/30/2023; P2003153, Exp. Date 5/31/2023; P2003155, Exp. Date 5/31/2023; P2003156, Exp. Date 5/31/2023; P2003154, Exp. Date 5/31/2023; P2003152, Exp. Date 5/31/2023; P2003157, Exp. Date 5/31/2023; P2003158, Exp. Date 5/31/2023; P2003159, Exp. Date 5/31/2023; P2003162, Exp. Date 5/31/2023; P2003160, Exp. Date 5/31/2023; P2003778, Exp. Date 6/30/2023; P2003779, Exp. Date 6/30/2023; P2004315, Exp. Date 6/30/2023; P2004818, Exp. Date 8/31/2023; P2004819, Exp. Date 8/31/2023; P2005158, Exp. Date 8/31/2023; P2005156, Exp. Date 8/31/2023; P2005157, Exp. Date 8/31/2023; P2005247, Exp. Date 9/30/2023; P2006641, Exp. Date 11/30/2023; P2101002, Exp. Date 1/31/2024; P2101004, Exp. Date 1/31/2024; P2101003, Exp. Date 1/31/2024; P2101006, Exp. Date 1/31/2024; P2101005, Exp. Date 1/31/2024; P2101008, Exp. Date 1/31/2024; P2101023, Exp. Date 1/31/2024; P2101022, Exp. Date 1/31/2024; P2101274, Exp. Date 2/29/2024; P2202085, Exp. Date 3/31/2025; b) P2002467, Exp. Date 4/30/2023; P2002466, Exp. Date 4/30/2023; P2002468, Exp. Date 4/30/2023; P2003780, Exp. Date 6/30/2023; P2005154, Exp. Date 8/31/2023; P2005244, Exp. Date 9/30/2023; P2005246, Exp. Date 9/30/2023; P2005809, Exp. Date 10/31/2023; P2005810, Exp. Date 10/31/2023; P2006642, Exp. Date 11/30/2023; P2006643, Exp. Date 11/30/2023; P2006644, Exp. Date 11/30/2023; P2006645, Exp. Date 11/30/2023; P2006646, Exp. Date 11/30/2023; P2006647, Exp. Date 11/30/2023; P2100463, Exp. Date 12/31/2023; P2100462, Exp. Date 12/31/2023; P2100464, Exp. Date 12/31/2023; P2100465, Exp. Date 12/31/2023; P2100498, Exp. Date 12/31/2023; P2100497, Exp. Date 12/31/2023; P2100499, Exp. Date 12/31/2023; P2100573 ,Exp. Date 1/31/2024; P2100572, Exp. Date 1/31/2024; P2100574, Exp. Date 1/31/2024; P2101007, Exp. Date 1/31/2024; P2202084, Exp. Date 3/31/2025; |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

United States including Puerto Rico and Canada

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Mar 8, 2023
- **Recall initiation date**: Feb 7, 2023
- **Center classification date**: Mar 2, 2023
- **Termination date**: Apr 22, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0417-2023%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Accord Healthcare, Inc. records](https://isitonrecall.com/brand/accord-healthcare-inc/)