Food, drugs, devices › Perrigo Company PLC

Drug recall: Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05,

FDA enforcement event 73101 · Class II · initiated 18 Jan 2016 · status Terminated · terminated 20 Jun 2016

DrugVoluntary: Firm initiated2 product recordsAllegan, MI

FDA enforcement event 73101 is a drug recall by Perrigo Company PLC of Allegan, MI, initiated 18 Jan 2016 and classified Class II, with 2 product records.

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. 46% of the 288 drug enforcement events initiated in 2016 carry the same class.

Status: Terminated, terminated 20 Jun 2016. Initiation: voluntary: firm initiated. Perrigo Company PLC has 9 enforcement events on this register, with a median of 2 product records 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

Perrigo Company PLC, Allegan, MI.

Reason for recall

"Labeling: label error on declared strength."

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0651-2016	Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.	948 units	Class II	Terminated	10 Feb 2016
D-0652-2016	Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157	918 units	Class II	Terminated	10 Feb 2016

Context

46%of 2016 drug events are Class II288 events that year

2product records in this eventfirm median: 2

9events on this register for the firm

Other enforcement events for Perrigo Company PLC

Initiated	Product (first record)	Type	Class	Records
26 Oct 2021	Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) per bottle, Distributed by Perrigo, Alleg	Drug	Class II	51
27 Jul 2021	EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22,	Drug	Class II	30
16 Sep 2020	Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma So	Drug	Class II	1
23 Oct 2019	Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-	Drug	Class II	17
20 Jun 2019	Parent's Choice Advantage Infant Formula Milk-Based Powder with Iron, 35 oz, 922 g, with UPC: 078742022468	Food	Class II	1
21 Jan 2019	Simple Truth Organic Banana, Strawberry & Apple Fruit Puree with Nonfat Greek Yogurt, 113 g, packed in a laminate pouch,	Food	Class II	1
8 Jan 2016	Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under	Drug	Class II	2
28 Sep 2015	Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand d	Drug	Class III	1

All 9 events for Perrigo Company PLC

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Labeling: label error on declared strength."

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: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 20 Jun 2016. "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.