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L. Perrigo Company

FDA Regulatory Profile

L. Perrigo Company has 28 FDA recalls, 34 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest recall
D-0900-2023 · Class II · Feb 9, 2023
Latest inspection
Feb 20, 2026 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls28Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections34Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0900-2023Class IIAllergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC…Feb 9, 2023
D-0905-2023Class IIAllergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by…Feb 9, 2023
D-0909-2023Class IIallergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC…Feb 9, 2023
D-0903-2023Class IIAllergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS…Feb 9, 2023
D-0907-2023Class IIFexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI…Feb 9, 2023
D-0904-2023Class IIaller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Packaged For: Your…Feb 9, 2023
D-0911-2023Class IIPicnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by…Feb 9, 2023
D-0910-2023Class IIallergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC…Feb 9, 2023
D-0908-2023Class IIFexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and…Feb 9, 2023
D-0912-2023Class IIAllergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC…Feb 9, 2023
D-0901-2023Class IINon-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons…Feb 9, 2023
D-0902-2023Class IIAllergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa…Feb 9, 2023
D-0906-2023Class IIallergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC…Feb 9, 2023
D-0266-2019Class IIAntacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, OTC, [Healthy Accents…Nov 6, 2018
D-0816-2018Class IIScopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count…May 11, 2018
D-0128-2018Class IIMaximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per…Nov 8, 2017
D-0925-2017Class IIIWalgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two plastic 12FL OZ (355 mL)…Jun 5, 2017
D-0887-2017Class IIOption 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive, 1 Tablet per box, Distributed By…Jun 1, 2017
D-0503-2017Class IIISalicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Yeruham, Israel…Feb 13, 2017
D-0504-2017Class IIISalicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruham, Israel 80500…Feb 13, 2017

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 20, 2026Allegan, MIDrugsVoluntary Action Indicated (VAI)1811666
Dec 5, 2025Holland, MIDrugsNo Action Indicated (NAI)1000518646
Mar 19, 2025Allegan, MIDrugsVoluntary Action Indicated (VAI)1811666
Oct 6, 2023Allegan, MIDrugsNo Action Indicated (NAI)1811666
Jun 14, 2023Holland, MIFood/CosmeticsNo Action Indicated (NAI)1000518646
Oct 22, 2019Holland, MIDrugsVoluntary Action Indicated (VAI)1000518646
Oct 16, 2019Holland, MIDrugsVoluntary Action Indicated (VAI)3004387156
Jan 17, 2019Allegan, MIDrugsVoluntary Action Indicated (VAI)1811666
Apr 10, 2018Holland, MIFood/CosmeticsNo Action Indicated (NAI)3004387156
Aug 17, 2017Holland, MIDrugsNo Action Indicated (NAI)1000518646
Apr 21, 2017Holland, MIFood/CosmeticsNo Action Indicated (NAI)1000518646
Oct 6, 2015Holland, MIFood/CosmeticsNo Action Indicated (NAI)3004387156
Dec 11, 2014Allegan, MIDrugsNo Action Indicated (NAI)1811666
Sep 16, 2014Holland, MIDrugsVoluntary Action Indicated (VAI)1000518646
Sep 4, 2014Allegan, MIDrugsVoluntary Action Indicated (VAI)1811666
Nov 7, 2013Allegan, MIDrugsVoluntary Action Indicated (VAI)1811666
May 17, 2013Allegan, MIDrugsNo Action Indicated (NAI)1811666
Aug 24, 2012Holland, MIDrugsVoluntary Action Indicated (VAI)1000518646
Jul 10, 2012Allegan, MIDrugsVoluntary Action Indicated (VAI)1811666
Jun 7, 2012Allegan, MIDrugsNo Action Indicated (NAI)1811666

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 1811666Allegan, MI21Feb 20, 2026
FEI 1000518646Holland, MI10Dec 5, 2025
FEI 3004387156Holland, MI3Oct 16, 2019

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.