CLASS II Drug recall · Reported 24 Apr 2024 · FDA Enforcement Report
S.P.Labs, Thyroid, Full Strength recalled by Specialty Process Labs
Specialty Process Labs is recalling S.P.Labs, Thyroid, Full Strength, 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
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-0446-2024
- 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
- Drug class
- Thyroid Medication
Timeline
| 1 Mar 2024 | Recall initiated by company | |
| 17 Apr 2024 | Classified by FDA | +47 days |
| 24 Apr 2024 | 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
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, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.
Where it was distributed
U.S. Nationwide.
Questions about this recall
Why was it recalled?
Failed Stability Specifications
Which lots are affected?
Lot #: H22212-FSV, Exp: 11/21/2024 1.0 kg pack size.
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.
Other products in this recall event
1 other product · FDA event 94268This product is part of a recall event; the main page for the event is S.P Labs, Thyroid recalled by Specialty Process Labs.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | S.P Labs, Thyroid recalled by Specialty Process Labs | Specialty Process Labs | Potency & Assay | Nationwide |
More recalls from Specialty Process Labs
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Thyroid 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 |