The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-1614-2020·Announced 2020-09-23

RLC Labs Recalls Subpotent WP Thyroid and Westhroid Pure Prescription Medications

RLC Labs Inc. is recalling specific lots of WP Thyroid and Westhroid Pure because FDA analysis found the products to be subpotent.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 I, which mandates a minimum severity score of 4 according to the rubric.

Plain-English summary

RLC Labs Inc. is recalling WP Thyroid and Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP, which are prescription-only medications containing Liothyronine (T3) and Levothyroxine (T4). The recall affects 30-count, 90-count, and 100-count bottles manufactured by RLC Labs Inc. in Phoenix, Arizona.

The recall was initiated because FDA analysis determined that the product is subpotent, meaning it does not contain the full amount of the active ingredient required by the label. The affected product is identified by Lot # 119142 with an expiration date of 01/2022.

The recalled products were distributed nationwide in the United States. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or healthcare provider for replacement or refund.

The recalled product

Product
WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 30-count bottles (NDC 64727-5550-4), b) 90-count bottles (NDC 64727-5550-6), c) 100-count bottles (NDC 64727-5550-1), 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 (2)

  • Lot #: 119142
  • Exp. Date 01/2022

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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