FDA-Drug2026-01-28Class IIMISBRANDING

Specialty Process Labs Thyroid USP recalled for subpotent drug

LABEL MIX UPNationwide distribution

Stop using Specialty Process Labs Thyroid USP

Specialty Process Labs is recalling one lot of Thyroid, USP (an active pharmaceutical ingredient used in manufacturing) because it does not meet strength standards. The affected lot may contain less active ingredient than labeled, which could affect the potency of products made with it.

  • If you manufacture, process, or repackage products using Thyroid, USP Lot #H22254-1XV (expiration 01/31/2027), stop using it immediately.
  • Contact Specialty Process Labs or the FDA for guidance on affected finished products.
  • Do not use this lot in any new manufacturing or compounding.
Hazard

Subpotent Drug

Sold states
U.S. Nationwide
Affected count
58 gms
Manufactured in
2001 W Lone Cactus Dr Ste B, Phoenix, AZ, United States
Products
Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0294-2026

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