Mylan Recalls Subpotent Levothyroxine Sodium Tablets Due to Stability Testing Failures
Mylan Pharmaceuticals is recalling specific lots of Levothyroxine Sodium Tablets because stability testing showed the drug was below specification.
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 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: The recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is subpotency (below specification) without reported illnesses, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottles (NDC 0378-1819-01). The recall involves 138,970 bottles distributed nationwide. The specific lots affected are Lot 3037531 (EXP 03/14) and Lot 3038284 (EXP 04/14).
The recall was initiated because assay results obtained during stability testing indicated that the drug was below specification. This means the tablets may not contain the full amount of the active ingredient required by the United States Pharmacopeia (USP).
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be returned to the pharmacy or supplier for replacement or refund. Patients should consult their healthcare provider regarding alternative treatment options if they have been using the affected product.
The recalled product
- Product
- Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 138,970
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 (1)
- Lot 3037531 EXP 03/14 Lot 3038284 EXP 04/14
Distribution
Distributed nationwide across the United States.
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