CLASS II Drug recall · Reported 24 Apr 2024 · FDA Enforcement Report

S.P Labs, Thyroid recalled by Specialty Process Labs

Specialty Process Labs is recalling S.P Labs, Thyroid, USP, distributed nationwide in the US. The recall was initiated on 1 Mar 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: L13152-1XV, Exp: 11/21/2024; a)1.00 kg, b)0.5 kg, c)100g pack sizes. Lot #: B10383-1XV, Exp: 02/14/2025, a)1 kg, b)0.5 kg, c)100g pack sizes. Lot #: B10453-1X, Exp: 02/15/2025, a)1.00 kg, b)0.5 kg, c)100g pack sizes. Lot #: C10803-1X, Exp: 03/23/2025, a)1.00 kg, c)100g pack sizes. Lot #: E11363-1X, Exp: 05/18/2025, a)1.00 kg, b)0.5 kg, c)100g pack sizes. Lot #: K12753-1X, Exp: 10/12/2025, a)1.00 kg pack sizes. Lot #: L13103-1X, Exp: 11/13/2025, a)1 kg, b)0.5 kg, c)100g pack sizes.
Quantity recalled217 units

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-0447-2024
FDA event ID
94268
Recalling firm
Specialty Process Labs, Phoenix, AZ
Classification
Class II
Status
Completed
Recall initiated
1 Mar 2024
FDA classified
17 Apr 2024
Reported
24 Apr 2024
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Potency & Assay

Timeline

1 Mar 2024Recall initiated by company
17 Apr 2024Classified by FDA+47 days
24 Apr 2024Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Stability Specifications

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

S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03

Where it was distributed

U.S. Nationwide.

Nationwide

Questions about this recall

Is S.P Labs, Thyroid, USP recalled?

Yes. Specialty Process Labs recalled S.P Labs, Thyroid, USP on 1 Mar 2024. The recall is Class II and its status is Completed. Recall number D-0447-2024.

Why was it recalled?

Failed Stability Specifications

Which lots are affected?

Lot #: L13152-1XV, Exp: 11/21/2024; a)1.00 kg, b)0.5 kg, c)100g pack sizes. Lot #: B10383-1XV, Exp: 02/14/2025, a)1 kg, b)0.5 kg, c)100g pack sizes. Lot #: B10453-1X, Exp: 02/15/2025, a)1.00 kg, b)0.5 kg, c)100g pack sizes. Lot #: C10803-1X, Exp: 03/23/2025, a)1.00 kg, c)100g pack sizes. Lot #: E11363-1X, Exp: 05/18/2025, a)1.00 kg, b)0.5 kg, c)100g pack sizes. Lot #: K12753-1X, Exp: 10/12/2025, a)1.00 kg pack sizes. Lot #: L13103-1X, Exp: 11/13/2025, a)1 kg, b)0.5 kg, c)100g pack sizes.

Where was it sold?

U.S. Nationwide.

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Specialty Process Labs

All 3
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIThyroid recalled by Specialty Process LabsSpecialty Process LabsPotency & AssayNationwide
DrugCLASS IIS.P.Labs, Thyroid, Full Strength recalled by Specialty Process LabsSpecialty Process LabsPotency & AssayNationwide