RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations
RLC Labs Inc. is recalling Nature-Throid tablets due to manufacturing deviations. The products were manufactured under conditions found to be subpotent.
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 typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report specific illnesses or injuries, aligning with a moderate severity rating for a CGMP deviation involving potential subpotency.
Plain-English summary
RLC Labs Inc. is recalling Nature-Throid, Thyroid USP tablets. The affected products contain liothyronine (T3) 4.5 mcg and levothyroxine (T4) 19 mcg and are packaged in 30, 60, 90, 100, and 1000-count bottles. The recall covers all lots with expiry dates between 10/2020 and 07/2023.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The source text states that the products were manufactured under the same conditions as those found to be subpotent.
The products were distributed nationwide in the United States. Consumers should stop using the recalled products and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- Nature-Throid, Thyroid USP [liothyronine (T3) 4.5 mcg and levothyroxine (T4) 19 mcg], 1/2 Grain (32.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3299-4; b) 60-count bottles, NDC 64727-3299-5; c) 90-count bottles, NDC 64727-3299-6; d) 100-count bottles, NDC…
- Manufacturer
- RLC Labs 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 (1)
- All lots with expiry between 10/2020-07/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by RLC Labs Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 24 products in this recall →Related recalls
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