---
title: "Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Phar... — FDA record D-0527-2025 | Is It on Recall"
description: "Failed Impurities/Degradation Specifications."
url: https://isitonrecall.com/recall/fda-drug-d-0527-2025-pitavastatin-tablets-1-mg-rx-only-90-tablets-manufactured-by-orient-pharma-co-ltd-8-kehu-1st-road-hu/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Che... — FDA record D-0527-2025

Reported ongoing

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 Jun 11, 2025. 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**: Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3631-98.
- **Reason**: Failed Impurities/Degradation Specifications.
- **Classification**: Class III
- **Recalling firm**: Orient Pharma Co., Ltd. Yunlin Plant
- **Quantity**: 20618 bottles
- **Agency-reported status**: Ongoing
- **Source record identifier**: D-0527-2025

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0527-2025%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 | P051001, P051002, & P051003, Exp Date 07/2025; P051005, Exp Date 10/2025; P051006, Exp Date 10/2025; P051007, Exp Date 01/2026; P051010, Exp Date 07/2026; P051011 & P051012, Exp Date 09/2026; P051013, P051014 and P051015, Exp Date 01/2027. |

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

## Distribution

NJ

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [New Jersey](https://isitonrecall.com/state/new-jersey/)

## Dates in the source

- **Report date**: Jul 9, 2025
- **Recall initiation date**: Jun 11, 2025
- **Center classification date**: Jul 16, 2025

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-0527-2025%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/) [Orient Pharma Co., Ltd. Yunlin Plant records](https://isitonrecall.com/brand/orient-pharma-co-ltd-yunlin-plant/)