RLC Labs Recalls Subpotent Nature Throid Thyroid Medication
RLC Labs Inc. is recalling Nature Throid thyroid medication because FDA analysis found the product 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies the agency classification as 'Class I', which mandates a severity score of 5 according to the rubric.
Plain-English summary
RLC Labs Inc. is recalling Nature Throid, 1/2 Grain (32.5 mg) Thyroid USP, a prescription-only medication containing Liothyronine (T3) and Levothyroxine (T4). The recall affects 90-count bottles (NDC 64727-3299-6) and 100-count bottles (NDC 64727-3299-1) with Lot # 099186 and an expiration date of 11/2022.
The FDA classified this as a Class I recall because analysis determined the product is subpotent, meaning it does not contain the full amount of the active ingredient required by the label. Subpotent medications may fail to provide the intended therapeutic effect for patients relying on the drug for thyroid hormone replacement.
The product was distributed nationwide in the United States. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Nature Throid, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 90-count bottles (NDC 64727-3299-6), b) 100-count bottles (NDC 64727-3299-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034
- 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 #: 099186
- Exp. Date 11/2022
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 →Related recalls
Same manufacturer · RLC Labs Inc.
See all →- SevereRLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations
FDA (Drugs) · 2020-09-23
- ModerateRLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations
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- ModerateRLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations
FDA (Drugs) · 2020-09-23
- ModerateRLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations
FDA (Drugs) · 2020-09-23
- SevereRLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations
FDA (Drugs) · 2020-09-23
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Similar recalls
- SeverePD-Rx Recalls Nature-Throid Tablets Due to CGMP Deviations and Sub-Potency Risk
FDA (Drugs) · 2020-10-14
- ModeratePreferred Pharmaceuticals Recalls Nature-Throid Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2020-09-30
- ModeratePreferred Pharmaceuticals Recalls Nature-Throid Tablets Due to CGMP Deviations
FDA (Drugs) · 2020-09-30
- CriticalAcella Recalls Subpotent NP Thyroid 15 Prescription Tablets
FDA (Drugs) · 2021-06-02
- CriticalAcella Recalls NP Thyroid 15 Tablets Due to Subpotent Levothyroxine
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