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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pitavastatin Tablets Recalled for Failed Impurity and Degradation Specifications

Agency Publication Date: July 16, 2025
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Summary

Orient Pharma Co., Ltd. Yunlin Plant is recalling 78,122 bottles of Pitavastatin (pitavastatin) tablets, including 57,504 bottles of the 2 mg strength and 20,618 bottles of the 1 mg strength. These prescription medications, manufactured for Teva Pharmaceuticals, were found to fail quality specifications for impurities and degradation during testing. If you are currently taking this medication, you should consult your healthcare provider or pharmacist before making any changes to your treatment.

Risk

The affected tablets may contain impurities or have broken down (degraded) beyond the levels permitted by pharmaceutical standards. This can potentially make the medication less effective or lead to exposure to unintended chemical byproducts, though the safety risk is currently categorized by the FDA as low.

What You Should Do

  1. This recall affects Pitavastatin Tablets in 1 mg and 2 mg strengths, sold in 90-count bottles under the Teva Pharmaceuticals brand.
  2. Identify if your medication is affected by checking the NDC number on the bottle label: NDC 0480-3632-98 for the 2 mg tablets and NDC 0480-3631-98 for the 1 mg tablets. See the Affected Products section below for the full list of affected lot numbers and expiration dates.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Pitavastatin Tablets (2 mg)
Variants: 2 mg, Tablet, Rx Only, 90-count bottle
Lot Numbers:
P061001 (Exp 07/2025)
P061002 (Exp 07/2025)
P061003 (Exp 07/2025)
P061004 (Exp 07/2025)
P061006 (Exp 07/2025)
P061007 (Exp 07/2025)
P061008 (Exp 08/2025)
P061009 (Exp 10/2025)
P061010 (Exp 10/2025)
P061011 (Exp 01/2026)
P061012 (Exp 01/2026)
P061013 (Exp 01/2026)
P061016 (Exp 04/2026)
P061017 (Exp 04/2026)
P061018 (Exp 04/2026)
P061019 (Exp 05/2026)
P061023 (Exp 01/2027)
NDC:
0480-3632-98

Manufactured for Teva Pharmaceuticals, Parsippany, NJ.

Product: Pitavastatin Tablets (1 mg)
Variants: 1 mg, Tablet, Rx Only, 90-count bottle
Lot Numbers:
P051001 (Exp 07/2025)
P051002 (Exp 07/2025)
P051003 (Exp 07/2025)
P051005 (Exp 10/2025)
P051006 (Exp 10/2025)
P051007 (Exp 01/2026)
P051010 (Exp 07/2026)
P051011 (Exp 09/2026)
P051012 (Exp 09/2026)
P051013 (Exp 01/2027)
P051014 (Exp 01/2027)
P051015 (Exp 01/2027)
NDC:
0480-3631-98

Manufactured for Teva Pharmaceuticals, Parsippany, NJ.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97076
Status: Active
Manufacturer: Orient Pharma Co., Ltd. Yunlin Plant
Sold By: Teva Pharmaceuticals; Pharmacies
Manufactured In: Taiwan
Units Affected: 2 products (57504 bottles; 20618 bottles)
Distributed To: New Jersey

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.