Food, drugs, devices › Acella Pharmaceuticals, LLC
Drug recall: NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count
FDA enforcement event 87843 is a drug recall by Acella Pharmaceuticals, LLC of Alpharetta, GA, initiated 29 Apr 2021 and classified Class I, with 5 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 19% of the 299 drug enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 13 Mar 2024. Initiation: voluntary: firm initiated. Acella Pharmaceuticals, LLC has 8 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Acella Pharmaceuticals, LLC, Alpharetta, GA.
Reason for recall
"Subpotent Drug"
Distribution
"Nationwide within the United States including Puerto Rico"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0395-2021 | NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 42192-327-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 | a) 66,155 bottles; b) 26,212 bottles | Class I | Terminated | 2 Jun 2021 |
| D-0396-2021 | NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles (NDC 42192-329-01) and b) 7-count bottles (NDC 42192-329-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 | a) 113,019 bottles; b) 44,900 bottles | Class I | Terminated | 2 Jun 2021 |
| D-0397-2021 | NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-330-01 | 154,726 bottles | Class I | Terminated | 2 Jun 2021 |
| D-0398-2021 | NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-331-01 | 79,344 bottles | Class I | Terminated | 2 Jun 2021 |
| D-0399-2021 | 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 | a) 69,289 bottles; b) 9,076 bottles | Class I | Terminated | 2 Jun 2021 |
Context
Other enforcement events for Acella Pharmaceuticals, LLC
All 8 events for Acella Pharmaceuticals, LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Subpotent Drug"
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within the United States including Puerto Rico"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 Mar 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.