Pitavastatin Tablet, Film Coated
FDA Recall NDC 0480-3633
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Pitavastatin (NDC 0480-3633). A significant event, classified as Class III, was initiated on Jun 11, 2025 by Teva Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Impurities/Degradation Specifications.
Jun 11, 2025
Jul 09, 2025
20618 bottles
Recall Profile & Regulatory Data
Event ID
97076
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Orient Pharma Co., Ltd. Yunlin Plant
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NJ
Product Description
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.
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
0480-3632-98Product
0480-3633-98Product
0480-3631-98Product
Class III Ongoing
Failed Impurities/Degradation Specifications.
Jun 11, 2025
Jul 09, 2025
57504 bottles
Recall Profile & Regulatory Data
Event ID
97076
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Orient Pharma Co., Ltd. Yunlin Plant
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NJ
Product Description
Pitavastatin Tablets, 2 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 0480-3632-98.
Batch or Lot Expiration Information
Lot# P061001, P061002, P061003, P061004, P061006 & P061007 Exp Date 07/2025; P061008, Exp Date 08/2025; P061009 & P061010 Exp Date 10/2025; P061011, P061012 & P061013 Exp Date 01/2026; P061016, P061017 & P061018, Exp Date 04/2026; P061019, Exp Date 05/2026; P061023, Exp Date 01/2027.
Affected Packages Involved in this Recall
0480-3632-98Product
0480-3633-98Product
0480-3631-98Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
