The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1606-2020·Announced 2020-09-23

RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

RLC Labs Inc. is recalling WP Thyroid 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 agency classification is FDA Class II, and the source text explicitly states the products were manufactured under conditions found to be subpotent, which constitutes a significant quality defect.

Plain-English summary

RLC Labs Inc. is voluntarily recalling WP Thyroid, Westhroid Pure, and Thyroid USP tablets. The affected products contain liothyronine (T3) 2.25 mcg and levothyroxine (T4) 9.5 mcg and are packaged in 30, 60, 90, 100, and 1,000-count bottles. The recall covers all lots with expiration dates between October 2020 and July 2023.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. According to the source text, the products were manufactured under the same conditions as those found to be subpotent. The agency has classified this recall as Class II.

The products were distributed nationwide in the United States. Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levothyroxine (T4) 9.5 mcg], 1/4 Grain (16.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-5450-4; b) 60-count bottles, NDC 64727-5450-5; c) 90-count bottles, NDC 64727-5450-6; d) 100-count…
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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