The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1601-2020·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 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as subpotency) are categorized as Severe (Score 4), as they are not Class I (Critical) but involve significant quality deviations.

Plain-English summary

RLC Labs Inc. is recalling Nature-Throid, Thyroid USP tablets, which contain liothyronine (T3) and levothyroxine (T4). The recall covers 1.75 Grain (113.75 mg) tablets packaged in 30-count, 60-count, 90-count, 100-count, and 1,000-count bottles. The affected products are distributed nationwide in the United States and include all lots with expiry dates between October 2020 and July 2023.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The source text indicates that the products were manufactured under the same conditions as those found to be subpotent. This suggests a potential issue with the potency or quality of the medication.

Consumers and healthcare providers should stop using the affected Nature-Throid tablets and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Nature-Throid, Thyroid USP [liothyronine (T3) 15.75 mcg and levothyroxine (T4) 66.5 mcg], 1.75 Grain (113.75 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3307-4; b) 60-count bottles, NDC 64727-3307-5; c) 90-count bottles, NDC 64727-3307-6; d) 100-count bottles, NDC…
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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