Food, drugs, devices › Lannett Company Inc.

Drug recall: Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: La

FDA enforcement event 91142 · Class III · initiated 9 Nov 2022 · status Terminated · terminated 8 Jun 2023

DrugVoluntary: Firm initiated2 product recordsSeymour, IN

Lannett Company Inc. (Seymour, IN) initiated this drug recall on 9 Nov 2022; FDA lists 2 product records under event 91142, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 18% of the 325 drug enforcement events initiated in 2022 carry the same class.

Status: Terminated, terminated 8 Jun 2023. Initiation: voluntary: firm initiated. Lannett Company Inc. has 14 enforcement events on this register, with a median of 1 product record 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

Lannett Company Inc., Seymour, IN.

Reason for recall

"Failed Impurity/Degradation Specifications"

Distribution

"Nationwide USA"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0160-2023	Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-1632-10	5,640 bottles	Class III	Terminated	25 Jan 2023
D-0161-2023	Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,000 bottle: 0527-1632-10	20,040 bottles	Class III	Terminated	25 Jan 2023

Context

18%of 2022 drug events are Class III325 events that year

2product records in this eventfirm median: 1

14events on this register for the firm

Other enforcement events for Lannett Company Inc.

Initiated	Product (first record)	Type	Class	Records
26 Jun 2026	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Exten	Drug	Class II	1
27 May 2026	Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philad	Drug	Class II	1
24 Apr 2026	Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136,	Drug	Class III	1
10 Oct 2025	Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., P	Drug	Class II	1
19 Aug 2025	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 10	Drug	Class II	1
11 Aug 2025	Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadel	Drug	Class II	1
25 Oct 2024	Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelp	Drug	Class II	1
9 Feb 2022	Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lanne	Drug	Class II	1
10 Aug 2020	Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Man	Drug	Class II	1
6 Dec 2019	Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philad	Drug	Class I	1

All 14 events for Lannett Company Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Impurity/Degradation Specifications"

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide USA"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 8 Jun 2023. "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.