Levothyroxine Sodium Tablets Recalled Due to Potency Failures
Viatris Inc. is recalling Levothyroxine Sodium 200 mcg tablets nationwide due to potency failures—some tablets are superpotent while others are subpotent. Affected lots expire July 2025; patients should contact their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II prescription drug recall with confirmed potency failures in a critical medication; no illnesses or injuries reported, but potency variations in thyroid hormone replacement pose inherent risk to patient safety.
Plain-English summary
Viatris Inc. is recalling Levothyroxine Sodium Tablets USP 200 mcg due to potency failures. The tablets being recalled contain incorrect potency levels—some are superpotent (containing more than the labeled dose) while others are subpotent (containing less than the labeled dose).
The recall affects 55,032 bottles distributed nationwide in the United States and Puerto Rico. The recalled tablets come in 90-count bottles (NDC 0378-1819-77) and 1000-count bottles (NDC 0378-1819-10), with lot numbers 8179847 and 3203518, both expiring July 2025.
Patients taking tablets from the recalled lots should not stop their medication without consulting their healthcare provider. Contact your healthcare provider or pharmacist if you may have been affected. Return affected tablets to your pharmacy for proper disposal.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Viatris Inc
- Category
- Drug
- Hazard
- potency-failure
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 (3)
- Lot #: a)8179847
- Exp. Date July 2025
- b) 3203518
Distribution
Distributed nationwide across the United States.
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