The Recall Desk
HighFDA (Drugs)·D-1603-2020·Announced 2020-09-23

RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

RLC Labs Inc. is recalling Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The product was manufactured under conditions associated with subpotency.

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: The recall is classified as FDA Class II due to CGMP deviations and potential subpotency. Per the rubric, risk-of-harm products where injury has not yet been reported are rated High (3).

Plain-English summary

RLC Labs Inc. is voluntarily recalling Nature-Throid, Thyroid USP tablets. The recall is due to Current Good Manufacturing Practice (CGMP) deviations. The source text states that the product was manufactured under the same conditions as those found to be subpotent.

The affected product includes Nature-Throid tablets containing liothyronine (T3) 20.25 mcg and levothyroxine (T4) 85.5 mcg. These are packaged in 30-count, 60-count, 90-count, 100-count, and 1,000-count bottles. The recall covers all lots with expiry dates between 10/2020 and 07/2023. The product was distributed nationwide in the United States.

Consumers should stop using the recalled product and contact their healthcare provider for guidance. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Nature-Throid, Thyroid USP [liothyronine (T3) 20.25 mcg and levothyroxine (T4) 85.5 mcg], 2.25 Grain (146.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3309-4; b) 60-count bottles, NDC 64727-3309-5; c) 90-count bottles, NDC 64727-3309-6; d) 100-count bottles, NDC 647
Manufacturer
RLC Labs Inc.
Category
Drug — Thyroid Hormone
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 →

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Same manufacturer · RLC Labs Inc.

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Same hazard · subpotency

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