Levothyroxine, Liothyronine

Levothyroxine, Liothyronine recalls: 10 FDA reports

Recalls involving Levothyroxine, Liothyronine. What was wrong with each batch, and how the FDA graded the risk.

10Reports
10Class I
0Ongoing
2021-06-02Most recent
10 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class I10

By year reported

YearReports
20205
20215
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Class I

NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and

D-0399-2021  ·  Class I  ·  reported 2021-06-02  ·  Terminated

Why it was recalled
Subpotent Drug
Product
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 went
Nationwide within the United States including Puerto Rico
How much
a) 69,289 bottles; b) 9,076 bottles
Class I

NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles (NDC 42192-329-01) and

D-0396-2021  ·  Class I  ·  reported 2021-06-02  ·  Terminated

Why it was recalled
Subpotent Drug
Product
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
Where it went
Nationwide within the United States including Puerto Rico
How much
a) 113,019 bottles; b) 44,900 bottles
Class I

NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactured For: Acella Pharmac

D-0397-2021  ·  Class I  ·  reported 2021-06-02  ·  Terminated

Why it was recalled
Subpotent Drug
Product
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
Where it went
Nationwide within the United States including Puerto Rico
How much
154,726 bottles
Class I

NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manufactured For: Acella Ph

D-0398-2021  ·  Class I  ·  reported 2021-06-02  ·  Terminated

Why it was recalled
Subpotent Drug
Product
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
Where it went
Nationwide within the United States including Puerto Rico
How much
79,344 bottles
Class I

NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and

D-0395-2021  ·  Class I  ·  reported 2021-06-02  ·  Terminated

Why it was recalled
Subpotent Drug
Product
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
Where it went
Nationwide within the United States including Puerto Rico
How much
a) 66,155 bottles; b) 26,212 bottles
Class I

NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Phar

D-0035-2021  ·  Class I  ·  reported 2020-10-28  ·  Terminated

Why it was recalled
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Product
NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-01
Where it went
Nationwide within the United States
How much
19,296 bottles
Class I

NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pha

D-0036-2021  ·  Class I  ·  reported 2020-10-28  ·  Terminated

Why it was recalled
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Product
NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-328-01
Where it went
Nationwide within the United States
How much
9816 bottles
Class I

NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pha

D-1299-2020  ·  Class I  ·  reported 2020-06-10  ·  Terminated

Why it was recalled
Superpotent Drug.
Product
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.
Where it went
Distributed Nationwide in the US and Puerto Rico
How much
29,304 bottles
Class I

NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella P

D-1298-2020  ·  Class I  ·  reported 2020-06-10  ·  Terminated

Why it was recalled
Superpotent Drug.
Product
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 went
Distributed Nationwide in the US and Puerto Rico
How much
112,140 bottles
Class I

NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured For: Acel

D-1300-2020  ·  Class I  ·  reported 2020-06-10  ·  Terminated

Why it was recalled
Superpotent Drug.
Product
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.
Where it went
Distributed Nationwide in the US and Puerto Rico
How much
49,128 bottles
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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