Home / Companies / Wockhardt Limited

Wockhardt Limited

FDA Regulatory Profile

Wockhardt Limited has 2 FDA recalls, 15 inspections, 0 510(k) clearances and 3 compliance actions on record.

What these totals cover: FDA records filed under the name "Wockhardt Limited" and its spelling variant "Wockhardt".

Latest recall: D-0913-2018 · Class III · Jun 19, 2018
Latest inspection: Jun 12, 2019 · NAI

Reviewing Wockhardt Limited as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Wockhardt Limited yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Is this your company or a supplier you list? Link to this FDA record from your site with a free button.

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	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	15	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	3	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

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

Recent recalls

2 recall records on Jun 19, 2018.

Number	Class	Product	Date
D-0913-2018	Class III	Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with…	Jun 19, 2018
D-0912-2018	Class III	Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non…	Jun 19, 2018

Recent FDA inspections

15 inspections from Apr 30, 2009 to Jun 12, 2019.

Date	Site	Product	Classification	FEI
Jun 12, 2019	Aurangabad, India	Drugs	No Action Indicated (NAI)	3002808503
Apr 12, 2019	Aurangabad, India	Drugs	No Action Indicated (NAI)	3002808503
Jan 12, 2016	Aurangabad, India	Drugs	Official Action Indicated (OAI)	3009278506
Dec 15, 2015	Ankleshwar, India	Drugs	Official Action Indicated (OAI)	3002808500
May 26, 2015	Aurangabad, India	Drugs	Official Action Indicated (OAI)	3005289335
Mar 17, 2015	Aurangabad, India	Drugs	Official Action Indicated (OAI)	3002808503
Feb 13, 2015	Aurangabad, India	Drugs	Official Action Indicated (OAI)	3004540156
Jul 31, 2013	Aurangabad, India	Drugs	Official Action Indicated (OAI)	3002808503
Jul 30, 2013	Aurangabad, India	Drugs	Official Action Indicated (OAI)	3004540156
Mar 22, 2013	Aurangabad, India	Drugs	Official Action Indicated (OAI)	3005289335
Jun 15, 2012	Aurangabad, India	Drugs	Voluntary Action Indicated (VAI)	3004540156
Feb 21, 2012	Ankleshwar, India	Drugs	Voluntary Action Indicated (VAI)	3002808500
Jan 27, 2012	Aurangabad, India	Drugs	Voluntary Action Indicated (VAI)	3005289335
Dec 17, 2010	Aurangabad, India	Drugs	No Action Indicated (NAI)	3002808503
Apr 30, 2009	Aurangabad, India	Drugs	Voluntary Action Indicated (VAI)	3005289335

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 3 compliance actions under Wockhardt Limited: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Dec 23, 2016.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

5 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002808503	Aurangabad, India	5	Jun 12, 2019
FEI 3009278506	Aurangabad, India	1	Jan 12, 2016
FEI 3002808500	Ankleshwar, India	2	Dec 15, 2015
FEI 3005289335	Aurangabad, India	4	May 26, 2015
FEI 3004540156	Aurangabad, India	3	Feb 13, 2015

Need more than this page shows? Ask about Wockhardt Limited in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.