The Recall Desk
HighFDA (Drugs)·D-0526-2025·Announced 2025-07-09

[pending] PITAVASTATIN (PITAVASTATIN CALCIUM)

Pending LLM rewrite. Source: FDA_DRUG D-0526-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Failed Impurities/Degradation Specifications.

The recalled product

Product
PITAVASTATIN (PITAVASTATIN CALCIUM)
Brand
PITAVASTATIN
Manufacturer
Orient Pharma Co., Ltd. Yunlin Plant
Category
Drug — Drugs

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • 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.

UPCs (3)

  • 0304803633985
  • 0304803631981
  • 0304803632988

Distribution

Distributed in 1 state:

  • NJ

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