Levothyroxine Sodium tablets recalled for impurity specification failure
Lupin Pharmaceuticals is recalling Levothyroxine Sodium 75 mcg tablets due to out-of-specification impurities detected in stability testing. Affected lot LA01276 (expiring 07/2026) was distributed to one Ohio distributor.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 recall of a prescription thyroid medication due to out-of-specification impurities and degradation detected in stability testing. No illnesses or injuries reported. Meets High severity criterion as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Levothyroxine Sodium 75 microgram tablets due to impurity specifications that were out of range. The issue was identified during a 3-month stability study of the drug substance.
The recall involves one lot: LA01276, expiring July 2026. Approximately 480 bottles containing 1000 tablets each were distributed to one distributor in Ohio.
Patients who may have received product from this lot should contact their pharmacy or healthcare provider with questions. Levothyroxine is a prescription medication for thyroid conditions.
The FDA has classified this as a Class II recall.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Thyroid Medication
- Hazard
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)
- Lot# LA01276
- Exp Date: 07/2026
UPCs (11)
- 0368180973010
- 0368180971016
- 0368180972013
- 0368180969013
- 0368180966012
- 0368180970019
- 0368180968016
- 0368180967019
- 0368180965015
- 0368180976011
- 0368180974017
Distribution
Distributed in 1 state:
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