Warfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
Crestline Pharmaceuticals is recalling two lots of warfarin sodium tablets after a labeling error swapped 2.5 mg and 5 mg strengths.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I for a narrow-therapeutic-index drug where mis-strength can cause fatal hemorrhage or stroke. Score 5.
Plain-English summary
Crestline Pharmaceuticals is recalling two lots of warfarin sodium tablets (USP) at the consumer level. During a packaging-line audit the company discovered that bottles labeled 2.5 mg may contain 5 mg tablets, and vice versa.
The FDA classified this recall as Class I because warfarin is a narrow-therapeutic-index anticoagulant; taking double the prescribed dose can cause life-threatening bleeding, and taking half can result in inadequate anticoagulation and increased clot risk.
Patients should not stop taking warfarin without consulting their prescriber, but should immediately check their bottle's lot number against the recall list and contact their pharmacy for a verified replacement if affected.
The recalled product
- Product
- Warfarin Sodium Tablets USP (2.5 mg / 5 mg)
- Manufacturer
- Crestline Pharmaceuticals Inc.
- Hazard
- mis-labeling
- wrong-strength
- life-threatening
- Affected units
- 42,000
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)
- CR-2026-0421A
- CR-2026-0428B
UPCs (2)
- 0573412080021
- 0573412080045
Distribution
Distributed nationwide across the United States.