S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Sp… recall
FDA recall D-0447-2024 · initiated Mar 1, 2024
Specialty Process Labs LLC recalled S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Us… in Mar 2024 — an FDA Class II recall (D-0447-2024) because Failed Stability Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Stability Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 217 units
Details
- Product
- 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
- Recalling company
- Specialty Process Labs LLC
- Classification
- Class II
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide.
- Initiated
- Mar 1, 2024
- FDA report date
- Apr 24, 2024
Frequently asked
- Was S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Us… recalled?
- Specialty Process Labs LLC recalled S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Us… in Mar 2024 — an FDA Class II recall (D-0447-2024) because Failed Stability Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Us… recalled?
- Per the FDA enforcement record, the reason for recall D-0447-2024 was: Failed Stability Specifications
- Is a recalled S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Us… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Us… are affected?
- Distributed: U.S. Nationwide.. The recall covers these lots — 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: 05/18/20…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0447-2024.