CLASS II Drug recall · Reported 23 Sep 2020 · FDA Enforcement Report
WP Thyroid, Westhroid Pure, 1.5 Grain (97.5 mg) Thyroid recalled
RLC Labs is recalling WP Thyroid, Westhroid Pure, 1.5 Grain (97.5 mg) Thyroid USP, distributed nationwide in the US. The recall was initiated on 25 Aug 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1611-2020
- FDA event ID
- 86343
- Recalling firm
- RLC Labs, Phoenix, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Aug 2020
- FDA classified
- 24 Sep 2020
- Reported
- 23 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Thyroid Medication
Timeline
| 25 Aug 2020 | Recall initiated by company | |
| 23 Sep 2020 | Published in enforcement report | +29 days |
| 24 Sep 2020 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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 Phoenix, AZ 85034
Where it was distributed
Nationwide in the United States
Questions about this recall
Why was it recalled?
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Which lots are affected?
All lots with expiry between 10/2020-07/2023
Where was it sold?
Nationwide in the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
23 other products · FDA event 86343This product is part of a recall event; the main page for the event is WP Thyroid, Westhroid Pure, 1 Grain (65 mg) Thyroid recalled by RLC Labs.
More recalls from RLC Labs
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Nature Throid, 3/4 Grain (48.75 mg) Thyroid recalled by RLC Labs | RLC Labs | Potency & Assay | Nationwide |
| Drug | CLASS I | Nature Throid, 2 Grain (130 mg) Thyroid USP [Liothyronine recalled | RLC Labs | Potency & Assay | Nationwide |
| Drug | CLASS II | Nature-Throid, Thyroid USP [liothyronine (T3) 18 mcg recalled | RLC Labs | Potency & Assay | Nationwide |
| Drug | CLASS I | Nature Throid, 1/2 Grain (32.5 mg) Thyroid recalled by RLC Labs | RLC Labs | Potency & Assay | Nationwide |
| Drug | CLASS II | WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid recalled | RLC Labs | Potency & Assay | Nationwide |
Other Wp Thyroid recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid recalled | RLC Labs | Potency & Assay | Nationwide |
| Drug | CLASS II | WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid recalled | RLC Labs | Potency & Assay | Nationwide |
| Drug | CLASS II | WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine recalled | RLC Labs | Potency & Assay | Nationwide |
| Drug | CLASS I | WP Thyroid, Westhroid Pure, 1/2 Grain recalled by RLC Labs | RLC Labs | Potency & Assay | Nationwide |
| Drug | CLASS II | WP Thyroid, Westhroid Pure, 1.25 Grain (81.25 mg) Thyroid recalled | RLC Labs | Potency & Assay | Nationwide |