The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1612-2020·Announced 2020-09-23

RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

RLC Labs Inc. is recalling WP Thyroid tablets because they were manufactured under conditions associated with subpotent products.

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 due to CGMP deviations and potential subpotency, which is a moderate risk as it may result in therapeutic failure but is not an immediate life-threatening hazard like contamination or mislabeling of a critical allergen.

Plain-English summary

RLC Labs Inc. is voluntarily recalling WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid USP tablets. The recall covers multiple package sizes, including 30, 60, 90, 100, and 1,000 tablets, with NDC codes 64727-6150-1 through 64727-6150-6. The affected lots have expiration 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 affected products were manufactured under the same conditions as those found to be subpotent. This means the tablets may not contain the full labeled amount of the active ingredient.

The product was distributed nationwide in the United States. Consumers and healthcare providers should stop using the recalled WP Thyroid tablets and contact their healthcare provider for guidance on alternative treatment options. The FDA has classified this recall as Class II.

The recalled product

Product
WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-6150-2 ; b) 30 Tablets, NDC 64727-6150-4; c) 60 Tablets, NDC 64727-6150-5; d) 90 Tablets, NDC 64727-6150-6; e) 100 Tablets, NDC 64727-6150-1; Rx only, Manufactured by: RLC…
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 →

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