Mayne Pharma Recalls Liothyronine Sodium Tablets for Dissolution Failures
Mayne Pharma Inc is recalling 11,364 bottles of Liothyronine Sodium Tablets 25 mcg because they failed dissolution specifications. The affected lot is distributed nationwide.
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: The recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct toxic contamination or structural defect, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Mayne Pharma Inc is voluntarily recalling 11,364 bottles of Liothyronine Sodium Tablets, USP 25 mcg, 100-count bottles. The product is distributed by Perrigo in Minneapolis, MN, and is available nationwide within the USA. The specific lot number is 16F649, with an expiration date of May 2018.
The recall was initiated because the tablets failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the medication breaks down properly in the body to release the active ingredient. When this specification is not met, the medication may not work as intended.
Consumers and healthcare providers should check their inventory for the specific lot number 16F649 and expiration date of May 2018. If the product matches these details, it should be returned to the pharmacy or distributor for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been using this specific lot.
The recalled product
- Product
- Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01
- Manufacturer
- Mayne Pharma Inc
- Category
- Drug — Prescription Medication
- Affected units
- 11,364
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: #:16F649
- Exp: May 2018
Distribution
Distributed nationwide across the United States.
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