Tranexamic Acid tablets recalled due to failed specification testing
AVKARE LLC is recalling Tranexamic Acid USP 650mg tablets nationwide due to failed quality control specifications for conductivity. No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 FDA Class III recall involves a manufacturing specification failure with no reported illnesses or injuries. FDA Class III recalls are typically scored 1 or 2; the failed purity and degradation specifications merits classification as Moderate rather than Low.
Plain-English summary
AVKARE LLC is recalling Tranexamic Acid USP 650 mg tablets nationwide. The recall affects 592 cartons with Lot 44286 (expiration February 2025) distributed throughout the United States. The affected product is identified by NDC 50268-772-13.
The product failed specification testing for conductivity, which is a quality control measure for pharmaceutical purity and degradation. Testing results were out of specification, indicating the product does not meet published manufacturing standards.
No illnesses or injuries have been reported. Consumers who have obtained this product should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- TRANEXAMIC ACID (TRANEXAMIC ACID)
- Brand
- TRANEXAMIC ACID
- Manufacturer
- AVKARE LLC
- Category
- Drug — Prescription Tablet
- Hazard
- Affected units
- 592
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 (1)
- Lot: 44286 Exp. 02/2025
Distribution
Distributed nationwide across the United States.
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