The Recall Desk
ModerateFDA (Drugs)·D-0871-2023·Announced 2023-06-21

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.

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 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
  • impurity
  • degradation

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.

Related recalls

Same brand · TRANEXAMIC ACID

Same category