Tranexamic Acid Tablets Recalled for Failed Manufacturing Specifications
Amring Pharmaceuticals is recalling 48,989 bottles of Lysteda (tranexamic acid) USP 650 mg tablets due to failed manufacturing specifications for impurities and degradation. The affected lots did not meet conductivity specifications during quality testing.
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 is an FDA Class III recall with no reported illnesses or injuries. The hazard is precautionary in nature—a manufacturing specification failure without established risk of actual harm.
Plain-English summary
Amring Pharmaceuticals Inc. is recalling 48,989 bottles of Lysteda (tranexamic acid) USP 650 mg tablets. The recalled lots are X220317A and X220318A, which were distributed nationwide in the USA. The product carries an expiration date of September 2025.
The recall was initiated due to failed manufacturing specifications for impurities and degradation. During quality testing, the affected lots obtained conductivity results that were out of specification.
Consumers and healthcare providers with the affected product should discontinue use and consult their pharmacy or healthcare provider. The recalled product should be quarantined pending return or destruction.
The recalled product
- Product
- TRANEXAMIC ACID (TRANEXAMIC ACID)
- Brand
- TRANEXAMIC ACID
- Manufacturer
- Amring Pharmaceuticals Inc
- Category
- Drug
- Hazard
- Affected units
- 48,989
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)
- Lots: X220317A and X220318A
- exp. date 09/25
Distribution
Distributed nationwide across the United States.
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