Prescription statin LIVALO tablets recalled due to foreign tablets in bottles
Kowa Pharmaceuticals America is recalling LIVALO (pitavastatin calcium) 4 mg tablets from a specific batch due to the presence of foreign tablets or capsules mixed with the correct medication. No illnesses have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This Class III recall involves a manufacturing contamination issue with foreign tablets mixed into medication bottles, posing a potential medication error risk. No illnesses or injuries have been reported, and the proactive recall results in a Moderate severity classification per the rubric guidance that Class III recalls are typically scored 1–2.
Plain-English summary
Kowa Pharmaceuticals America is recalling specific bottles of LIVALO (pitavastatin calcium) 4 mg tablets due to a manufacturing quality control issue. The affected bottles contain foreign tablets or capsules mixed with the correct medication, which could result in patients unknowingly taking the wrong drug.
The recall affects lot 3231300 (expiring August 2027) distributed in Pennsylvania, Ohio, and Texas. Approximately 5,328 bottles are involved. Affected bottles can be identified by lot number 3231300 and expiration date of August 2027.
Patients taking LIVALO from the recalled lot should contact their healthcare provider or pharmacist immediately to verify their supply and confirm whether they may have received affected medication. While no illnesses have been reported, patients should not abruptly stop taking their medication without consulting their healthcare professional first.
Consumers with affected bottles should not use the product and should return it to their pharmacy or contact the manufacturer for further instructions.
The recalled product
- Product
- LIVALO (PITAVASTATIN CALCIUM)
- Brand
- LIVALO
- Manufacturer
- Kowa Pharmaceuticals America
- Category
- Drug — Prescription / Statin
- Hazard
- foreign-tablets
- contamination
- medication-error
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 (2)
- Lot#: 3231300
- Exp 8/2027
UPCs (2)
- 0366869404909
- 0366869104908
Distribution
Distributed in 3 states:
- OH
- PA
- TX
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