The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1611-2020·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 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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential subpotency which poses a significant health risk to patients relying on the medication.

Plain-English summary

RLC Labs Inc. is recalling WP Thyroid, Westhroid Pure, 1.5 Grain (97.5 mg) Thyroid USP tablets. The recall includes multiple package sizes: 1,000, 30, 60, 90, and 100 tablets. 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 states that the products were manufactured under the same conditions as those found to be subpotent. This indicates a potential risk that the medication may not contain the full labeled amount of the active ingredient.

The affected products were distributed nationwide in the United States. Consumers who have these specific lots of WP Thyroid should stop using them and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.

The recalled product

Product
WP Thyroid, Westhroid Pure, 1.5 Grain (97.5 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5850-2 ; b) 30 Tablets, NDC 64727-5850-4; c) 60 Tablets, NDC 64727-5850-5; d) 90 Tablets, NDC 64727-5850-6; e) 100 Tablets, NDC 64727-5850-1; 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 →

Related recalls

Same manufacturer · RLC Labs Inc.

See all →

Same hazard · subpotency

See all →

Similar recalls