CLASS II ONGOING Drug recall · Reported 28 Jan 2026 · FDA Enforcement Report
Thyroid recalled by Specialty Process Labs
Specialty Process Labs is recalling Thyroid, USP, distributed nationwide in the US. The recall was initiated on 16 Jan 2026 and the FDA has classified it as Class II.
Check your package
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-0294-2026
- FDA event ID
- 98307
- Recalling firm
- Specialty Process Labs, Phoenix, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Jan 2026
- FDA classified
- 21 Jan 2026
- Reported
- 28 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Thyroid Medication
Timeline
| 16 Jan 2026 | Recall initiated by company | |
| 21 Jan 2026 | Classified by FDA | +5 days |
| 28 Jan 2026 | Published 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
Subpotent Drug
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
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
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot #H22254-1XV; Exp. 01/31/2027
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 26 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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | S.P.Labs, Thyroid, Full Strength recalled by Specialty Process Labs | Specialty Process Labs | Potency & Assay | Nationwide |
| Drug | CLASS II | S.P Labs, Thyroid recalled by Specialty Process Labs | Specialty Process Labs | Potency & Assay | Nationwide |
Other Thyroid recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Thyroid Tablets, USP, 1/2 Grain (30 mg) recalledThyroid | Vitruvias Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS II | Thyroid Powder, USP/drum recalled by LGM Pharma | LGM Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain recalled | Humco Holding Group | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain recalled | Humco Holding Group | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain recalled | Humco Holding Group | Manufacturing (CGMP) Deviations | Nationwide |