The Recall Desk
HighFDA (Drugs)·D-0447-2024·Announced 2024-04-24

Specialty Process Labs Recalls Thyroid USP Drug Ingredient for Failed Stability

Specialty Process Labs is recalling Thyroid, USP, a pharmaceutical ingredient used in drug manufacturing, due to failed stability specifications. Seven lots distributed nationwide are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II drug recall for failed stability specifications with no reported illnesses or injuries. Stability failures represent a substantive quality/efficacy risk where the product may not maintain its labeled potency; this constitutes theoretical harm per the rubric, placing it at High (3) rather than Moderate.

Plain-English summary

Specialty Process Labs LLC is recalling Thyroid, USP, an active pharmaceutical ingredient for use in manufacturing, processing, or repackaging. The product was distributed nationwide throughout the United States.

The recall was initiated because the product failed to meet established stability specifications. Seven lot numbers are affected with expiration dates ranging from November 2024 to October 2025, available in three package sizes: 100 grams, 500 milligrams, and 1 kilogram.

Approximately 217 units of the recalled ingredient have been distributed in the United States.

The recalled product

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
Manufacturer
Specialty Process Labs LLC
Category
Drug
Hazard
  • failed-stability

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 (18)

  • 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
  • c)100g pack sizes. Lot #: B10453-1X
  • Exp: 02/15/2025
  • c)100g pack sizes. Lot #: C10803-1X
  • Exp: 03/23/2025
  • c)100g pack sizes. Lot #: E11363-1X
  • Exp: 05/18/2025
  • c)100g pack sizes. Lot #: K12753-1X
  • Exp: 10/12/2025
  • a)1.00 kg pack sizes. Lot #: L13103-1X
  • Exp: 11/13/2025
  • c)100g pack sizes.

Distribution

Distributed nationwide across the United States.

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