Food, drugs, devices › Par Pharmaceutical Inc.

Drug recall: PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, ND

FDA enforcement event 85136 · Class III · initiated 4 Mar 2020 · status Terminated · terminated 9 Apr 2021

DrugVoluntary: Firm initiated1 product recordChestnut Ridge, NY

Par Pharmaceutical Inc. (Chestnut Ridge, NY) initiated this drug recall on 4 Mar 2020; FDA lists 1 product record under event 85136, 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. 21% of the 342 drug enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 9 Apr 2021. Initiation: voluntary: firm initiated. Par Pharmaceutical Inc. has 11 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

Par Pharmaceutical Inc., Chestnut Ridge, NY.

Reason for recall

"Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg"

Distribution

"U.S.A. Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1035-2020	PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31	13008 bottles	Class III	Terminated	25 Mar 2020

Context

21%of 2020 drug events are Class III342 events that year

1product record in this eventfirm median: 1

11events on this register for the firm

Other enforcement events for Par Pharmaceutical Inc.

Initiated	Product (first record)	Type	Class	Records
10 Aug 2020	BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01	Drug	Class II	1
30 Mar 2020	Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.	Drug	Class II	1
10 Feb 2020	Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Alm	Drug	Class III	1
30 Apr 2019	Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestn	Drug	Class I	1
6 Sep 2018	Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: P	Drug	Class III	1
5 Oct 2016	Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in In	Drug	Class II	1
27 Sep 2016	Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (ND	Drug	Class III	5
26 Oct 2015	Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct	Drug	Class III	2
12 Feb 2015	Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharma	Drug	Class II	1
24 Nov 2014	HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, In	Drug	Class II	1

All 11 events for Par Pharmaceutical Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg"

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: "U.S.A. Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 9 Apr 2021. "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.