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

Class I FDA enforcement event 86467. Recall start date: 17 Sep 2020. Status in the FDA record: Terminated. Termination date: 8 Dec 2022.

Reason for recall, in the words of FDA

Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.

Class I, in the words of FDA

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

Acella Pharmaceuticals, LLC started this drug recall on 17 Sep 2020. The firm address in the FDA record is in Alpharetta, GA. FDA put the recall in Class I. FDA event 86467 has 2 product records. The first FDA enforcement report date is 28 Oct 2020. The record gives the status Terminated, with the termination date 8 Dec 2022.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide within the United States

Recalling firm

Acella Pharmaceuticals, LLC, Alpharetta, GA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 86467: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0035-2021	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	19,296 bottles	Class I	Terminated	28 Oct 2020
D-0036-2021	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	9816 bottles	Class I	Terminated	28 Oct 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Drug events that started in 2020: 342
Share of these events in Class I: 15%
Product records in this event: 2Median of the firm: 2
Events of the firm on the register: 8

Other events of the firm

Other FDA enforcement events of Acella Pharmaceuticals, LLC
Initiated	Product (first record)	Type	Class	Records
20 Apr 2026	NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LL	Drug	Class II	1
29 Sep 2025	Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alphar	Drug	Class II	1
24 Apr 2024	Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, L	Drug	Class III	1
14 Nov 2022	Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10,	Drug	Class III	2
14 Nov 2022	Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,)	Drug	Class III	1
29 Apr 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	Drug	Class I	5
22 May 2020	NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuti	Drug	Class I	3

Acella Pharmaceuticals, LLC: all 8 events

Official channels

FDA enforcement report D-0035-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 86467. https://recallregister.com/fda/i/86467/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide within the United States
What quantity of product is in FDA event 86467?: The event has 2 product records. The first record gives this quantity: 19,296 bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2020 have the same class?: 15% of the 342 drug events that started in 2020 are in Class I.