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Wockhardt Usa Inc.

FDA Regulatory Profile

Wockhardt Usa Inc. has 45 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record.

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

Latest recall: D-0051-2018 · Class III · Aug 22, 2017
Latest inspection: Jun 6, 2024 · VAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	45	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	1	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Wockhardt Usa Inc.'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	1	0
2023	0	0
2022	0	0
2021	0	0
2020	0	0
2019	0	0
2018	0	0
2017	0	1

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

45 recall records from Nov 27, 2013 to Aug 22, 2017. Showing the 20 most recent. View all 45 recall records

Number	Class	Product	Date
D-0051-2018	Class III	Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited…	Aug 22, 2017
D-1347-2015	Class II	Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited…	Jul 29, 2015
D-1346-2015	Class II	Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited…	Jul 29, 2015
D-1263-2015	Class II	Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and…	Apr 22, 2015
D-1261-2015	Class II	Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500…	Apr 22, 2015
D-1264-2015	Class II	Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by…	Apr 22, 2015
D-1256-2015	Class II	Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01)…	Apr 22, 2015
D-1260-2015	Class II	Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B)…	Apr 22, 2015
D-1270-2015	Class II	Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles…	Apr 22, 2015
D-1271-2015	Class II	Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles…	Apr 22, 2015
D-1257-2015	Class II	Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500…	Apr 22, 2015
D-1249-2015	Class II	Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt…	Apr 22, 2015
D-1248-2015	Class II	Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B)…	Apr 22, 2015
D-1273-2015	Class II	Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by…	Apr 22, 2015
D-1262-2015	Class II	Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01)…	Apr 22, 2015
D-1243-2015	Class II	Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by…	Apr 22, 2015
D-1266-2015	Class II	Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the…	Apr 22, 2015
D-1259-2015	Class II	Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500…	Apr 22, 2015
D-1244-2015	Class II	Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B)…	Apr 22, 2015
D-1255-2015	Class II	Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and…	Apr 22, 2015

Recent FDA inspections

1 inspection on Jun 6, 2024.

Date	Site	Product	Classification	FEI
Jun 6, 2024	Parsippany, NJ	Drugs	Voluntary Action Indicated (VAI)	3003060524

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.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3003060524	Parsippany, NJ	1	Jun 6, 2024

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