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Legacy Pharmaceutical Packaging LLC

FDA Regulatory Profile

Legacy Pharmaceutical Packaging LLC has 12 FDA recalls, 16 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest recall
D-0205-2024 · Class II · Dec 11, 2023
Latest inspection
Feb 29, 2024 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls12Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections16Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0205-2024Class IISertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR…Dec 11, 2023
D-1626-2020Class IIIMetformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage…Sep 24, 2020
D-1263-2019Class IILosartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co…Apr 24, 2019
D-1075-2019Class IILosartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co…Mar 1, 2019
D-1050-2019Class IILosartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart…Mar 1, 2019
D-1049-2019Class IILosartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart…Mar 1, 2019
D-1048-2019Class IILosartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart…Mar 1, 2019
D-0606-2017Class IIATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The Kroger Co., 1014 Vine…Mar 7, 2017
D-1363-2014Class IIPantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages…Apr 9, 2014
D-1279-2014Class IIFluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville…Feb 14, 2014
D-319-2013Class IIWalmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufactured by: InvaGen…Apr 22, 2013
D-580-2013Class IIILorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI…Mar 27, 2013

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 29, 2024Earth City, MODrugsVoluntary Action Indicated (VAI)3004453700
Nov 21, 2023Hazelwood, MOFood/CosmeticsNo Action Indicated (NAI)3017216436
Jun 30, 2023Earth City, MODrugsOfficial Action Indicated (OAI)3004453700
Jun 20, 2023Earth City, MODevicesVoluntary Action Indicated (VAI)3004453700
Apr 27, 2022Earth City, MODrugsOfficial Action Indicated (OAI)3004453700
Jan 16, 2020Earth City, MODevicesVoluntary Action Indicated (VAI)3004453700
Jan 25, 2019Earth City, MODrugsVoluntary Action Indicated (VAI)3004453700
May 26, 2017Earth City, MOFood/CosmeticsNo Action Indicated (NAI)3004453700
Jul 9, 2015Earth City, MODrugsVoluntary Action Indicated (VAI)3004453700
Aug 29, 2014Earth City, MODrugsVoluntary Action Indicated (VAI)3004453700
Nov 26, 2013Earth City, MODrugsVoluntary Action Indicated (VAI)3004453700
Nov 26, 2013Earth City, MOFood/CosmeticsVoluntary Action Indicated (VAI)3004453700
Jun 18, 2013Earth City, MODrugsVoluntary Action Indicated (VAI)3004453700
Dec 20, 2011Earth City, MODrugsVoluntary Action Indicated (VAI)3004453700
Nov 16, 2011Earth City, MOFood/CosmeticsVoluntary Action Indicated (VAI)3004453700
Apr 26, 2010Earth City, MODrugsVoluntary Action Indicated (VAI)3004453700

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 3004453700Earth City, MO15Feb 29, 2024
FEI 3017216436Hazelwood, MO1Nov 21, 2023

FDA data resources

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