Food, drugs, devices › Lannett Company, Inc.

Drug recall: Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philad

FDA enforcement event 84427 · Class I · initiated 6 Dec 2019 · status Terminated · terminated 13 Jul 2020

DrugVoluntary: Firm initiated1 product recordPhiladelphia, PA

Lannett Company, Inc. (Philadelphia, PA) initiated this drug recall on 6 Dec 2019; FDA lists 1 product record under event 84427, classified Class I.

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. 10% of the 362 drug enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 13 Jul 2020. 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., Philadelphia, PA.

Reason for recall

"Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count."

Distribution

"Nationwide within the United States"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0630-2020	Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80	16,668 bottles	Class I	Terminated	25 Dec 2019

Context

10%of 2019 drug events are Class I362 events that year

1product record 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 Nov 2022	Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: La	Drug	Class III	2
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

All 14 events for Lannett Company, Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count."

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"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 13 Jul 2020. "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.