CLASS I Drug recall · Reported 2 Jun 2021 · FDA Enforcement Report
NP Thyroid, USP 2 grain (120 mg) recalled by Acella Pharmaceuticals
Acella Pharmaceuticals is recalling NP Thyroid, USP 2 grain (120 mg), distributed nationwide in the US. The recall was initiated on 29 Apr 2021 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-0399-2021
- FDA event ID
- 87843
- Recalling firm
- Acella Pharmaceuticals, Alpharetta, GA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 29 Apr 2021
- FDA classified
- 24 May 2021
- Reported
- 2 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Potency & Assay
- Drug class
- Thyroid Medication
Timeline
| 29 Apr 2021 | Recall initiated by company | |
| 24 May 2021 | Classified by FDA | +25 days |
| 2 Jun 2021 | Published in enforcement report | +9 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
NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and b) 7-count bottles (NDC 42192-328-07) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Where it was distributed
Nationwide within the United States including Puerto Rico
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot #: a) M328H19-2B, M328J19-11, M328J19-2A, M328J19-3A, M328J19-4A M328J19-5A, M328J19-6A, M328J19-7A, Exp. 08/31/2021, M328K19-2, M328K19-4A, Exp. 09/30/2021; b) M328J19-9B Exp. 08/31/2021
Where was it sold?
Nationwide within the United States including 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
4 other products · FDA event 87843| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | NP Thyroid, USP 1/2 grain (30 mg) recalled by Acella Pharmaceuticals | Acella Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS I | NP Thyroid, USP 1 grain (60 mg) recalled by Acella Pharmaceuticals | Acella Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS I | NP Thyroid, USP 1&1/2 grain (90 mg) recalled by Acella Pharmaceuticals | Acella Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS I | NP Thyroid, USP 1/4 grain (15 mg) recalled by Acella Pharmaceuticals | 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 |
Other Np Thyroid recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | NP Thyroid, USP 1/4 grain (15 mg) recalled by Acella Pharmaceuticals | Acella Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | NP Thyroid, USP 1&1/2 grain (90 mg) recalled by Acella Pharmaceuticals | Acella Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | NP Thyroid, USP 1 grain (60 mg) recalled by Acella Pharmaceuticals | Acella Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | NP Thyroid, USP 1/2 grain (30 mg) recalled by Acella Pharmaceuticals | Acella Pharmaceuticals | Potency & Assay | Nationwide |