Food, drugs, devices › Lannett Company, Inc.

Drug recall: Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Man

FDA enforcement event 86130 · Class II · initiated 10 Aug 2020 · status Terminated · terminated 22 Jul 2022

DrugVoluntary: Firm initiated1 product recordPhiladelphia, PA

FDA enforcement event 86130 is a drug recall by Lannett Company, Inc. of Philadelphia, PA, initiated 10 Aug 2020 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 64% of the 342 drug enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 22 Jul 2022. 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

"Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg"

Distribution

"US Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1508-2020	Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Manufactured by: Tianjin Tianyao Pharmaceuticals Co., Ltd No. 221 Huanghai Road, Tianjin Economical-Technological Development Area, Tianjin, China 300457 NDC 0527-2931-37	N/A	Class II	Terminated	26 Aug 2020

Context

64%of 2020 drug events are Class II342 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
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: "Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

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

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 22 Jul 2022. "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.