CLASS I Drug recall · Reported 10 Jun 2020 · FDA Enforcement Report
NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg) recalled
Acella Pharmaceuticals is recalling NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), distributed nationwide in the US. The recall was initiated on 22 May 2020 and the FDA has classified it as Class I.
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-1298-2020
- FDA event ID
- 85721
- Recalling firm
- Acella Pharmaceuticals, Alpharetta, GA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 22 May 2020
- FDA classified
- 8 Jun 2020
- Reported
- 10 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Potency & Assay
- Drug class
- Thyroid Medication
Timeline
| 22 May 2020 | Recall initiated by company | |
| 8 Jun 2020 | Classified by FDA | +17 days |
| 10 Jun 2020 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent 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
NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-329-01.
Where it was distributed
Distributed Nationwide in the US and Puerto Rico
Questions about this recall
Why was it recalled?
Superpotent Drug.
Which lots are affected?
Lots: M329H18-1, Exp. JUL-2020; M329J18-1, M329J18-2, M329J18-3 Exp. AUG-2020; M329M18-2 Exp. NOV-2020, M329A19-1 Exp. DEC-2020.
Where was it sold?
Distributed Nationwide in the US and Puerto Rico
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 22 Oct 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
2 other products · FDA event 85721This product is part of a recall event; the main page for the event is NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg) recalled | Acella Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS I | NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg) recalled | Acella Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Acella Pharmaceuticals
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Naproxen Oral Suspension, USP, 125 mg recalled by Acella PharmaceuticalsNaproxen | Acella Pharmaceuticals | Lead & Heavy Metals | Nationwide |
| Drug | CLASS II | Doxycycline Hyclate Tablets, USP 100 mg* recalledDoxycycline | Acella Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Sodium Sulfacetamide 10% - Sulfur 5% Cleanser recalled | Acella Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads recalled | Acella Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Phenytoin Sodium Injection, USP 100 mg recalledPhenytoin Sodium | Acella Pharmaceuticals | Packaging Defects | Nationwide |