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Apothecary Products, LLC FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection NAI · May 9, 2023
Last warning letter 2010

Inspections 10

1 OAI

Recalls 2

0 Class I (0%)

Warning letters 1 Latest Jan 5, 2010

510(k) clearances 6 Latest Jul 9, 2014

Apothecary Products, LLC has 2 FDA recalls, 10 inspections, 6 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Apothecary Products, LLC, the most recent on Jan 5, 2010.

What these totals cover: FDA records filed under the name "Apothecary Products, LLC" and its spelling variant "Apothecary Products".

Latest recall: Z-1702-2023 · Class II · Mar 30, 2023
Latest inspection: May 9, 2023 · NAI
Latest 510(k): Jul 9, 2014

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	2	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	6	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	10	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Apothecary Products, LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Apothecary Products, LLC: FDA inspections per year

Year	Inspections	Recall records
2026	0	0
2025	0	0
2024	0	0
2023	1	2
2022	0	0
2021	0	0
2020	0	0
2019	2	0
2018	0	0
2017	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Apothecary Products, LLC FDA Warning Letters

1 warning letter on Jan 5, 2010.

Issued	Subject	Issuing office	Close-out letter
Jan 5, 2010 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent recalls

2 recall records on Mar 30, 2023.

Number	Class	Product	Date
Z-1702-2023	Class II	Eye and Ear Dropper, Product Code 67082	Mar 30, 2023
Z-1703-2023	Class II	Medicine Dropper, Product Code K508	Mar 30, 2023

Recent FDA inspections

10 inspections from Jun 1, 2009 to May 9, 2023.

Date	Site	Product	Classification	FEI
May 9, 2023	Burnsville, MN	Food/Cosmetics	No Action Indicated (NAI)	2183416
Sep 3, 2019	Burnsville, MN	Devices	Voluntary Action Indicated (VAI)	2183416
Feb 25, 2019	Burnsville, MN	Food/Cosmetics	No Action Indicated (NAI)	2183416
May 5, 2016	Burnsville, MN	Devices	No Action Indicated (NAI)	2183416
Aug 14, 2015	Burnsville, MN	Devices	No Action Indicated (NAI)	2183416
Dec 18, 2013	Saint Charles, MI	Devices	No Action Indicated (NAI)	1831949
Sep 9, 2010	Saint Charles, MI	Devices	No Action Indicated (NAI)	1831949
Oct 8, 2009	Burnsville, MN	Drugs	No Action Indicated (NAI)	2183416
Sep 30, 2009	Saint Charles, MI	Devices	Official Action Indicated (OAI)	1831949
Jun 1, 2009	Saint Charles, MI	Devices	Voluntary Action Indicated (VAI)	1831949

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

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Apothecary Products, LLC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jan 5, 2010.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 2183416	Burnsville, MN	6	May 9, 2023
FEI 1831949	Saint Charles, MI	4	Dec 18, 2013

Recent 510(k) clearances

6 510(k) clearances from Feb 4, 1984 to Jul 9, 2014.

K-Number	Device	Date
K140409	FLENTS PLASTIC EYE WASH CUP	Jul 9, 2014
K111856	SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE	Jul 14, 2011
K041766	EZY-TRAVEL WRISTBAND	Nov 26, 2004
K020296	ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057	Jun 25, 2002
K892242	PATIENT EXAMINATION GLOVES (LATEX)	May 12, 1989
K833311	NITROGLYCERINE CONTAINER	Feb 4, 1984

Apothecary Products, LLC and the FDA: common questions

Has Apothecary Products, LLC received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Apothecary Products, LLC. The most recent is dated Jan 5, 2010.

Has Apothecary Products, LLC received an FDA Form 483?

FDA has not published a Form 483 for "Apothecary Products, LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Apothecary Products, LLC?

The most recent FDA inspection on file ended May 9, 2023 at Burnsville, MN and was classified NAI. FDA has 10 inspections of Apothecary Products, LLC on file, 1 of them classified OAI (official action indicated).

Has Apothecary Products, LLC had an FDA recall?

Yes. Apothecary Products, LLC has 2 FDA recalls on record. The most recent started Mar 30, 2023.

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