The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1607-2020·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 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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant health risks, such as subpotent medication which may lead to treatment failure, are categorized as Severe.

Plain-English summary

RLC Labs Inc. is recalling WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP tablets. The recall affects multiple package sizes, including 30, 60, 90, 100, and 1,000 tablets, with NDC codes 64727-5550-4, 64727-5550-5, 64727-5550-6, 64727-5550-1, and 64727-5550-2 respectively.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the product was manufactured under the same conditions as those found to be subpotent. This classification indicates a potential risk that the medication may not contain the intended amount of active ingredient.

The affected lots have expiration dates between October 2020 and July 2023. The product was distributed nationwide in the United States. Consumers should stop using the recalled medication and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.

The recalled product

Product
WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5550-2 ; b) 30 Tablets, NDC 64727-5550-4; c) 60 Tablets, NDC 64727-5550-5; d) 90 Tablets, NDC 64727-5550-6; e) 100 Tablets, NDC 64727-5550-1; Rx only, Manufactured by: RLC Labs…
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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