Food, drugs, devices › Wockhardt Usa Inc.

Drug recall: buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited,

FDA enforcement event 68813 · Class III · initiated 14 Jul 2014 · status Terminated · terminated 12 Jan 2015

DrugVoluntary: Firm initiated1 product recordParsippany, NJ

FDA enforcement event 68813 is a drug recall by Wockhardt Usa Inc. of Parsippany, NJ, initiated 14 Jul 2014 and classified Class III, with 1 product record.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 27% of the 313 drug enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 12 Jan 2015. Initiation: voluntary: firm initiated. Wockhardt Usa Inc. has 10 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Wockhardt Usa Inc., Parsippany, NJ.

Reason for recall

"Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed."

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1513-2014	buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.	840 bottles	Class III	Terminated	13 Aug 2014

Context

27%of 2014 drug events are Class III313 events that year

1product record in this eventfirm median: 1

10events on this register for the firm

Other enforcement events for Wockhardt Usa Inc.

Initiated	Product (first record)	Type	Class	Records
22 Aug 2017	Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Ar	Drug	Class III	1
29 Jul 2015	Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distribute	Drug	Class II	2
22 Apr 2015	Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited,	Drug	Class II	35
12 Mar 2015	Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02,	Drug	Class II	1
24 Jul 2014	Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-coun	Drug	Class II	1
17 Apr 2014	Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000	Drug	Class III	1
10 Apr 2014	Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limite	Drug	Class II	1
1 Apr 2014	Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited,	Drug	Class II	1
27 Nov 2013	Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limite	Drug	Class II	1

All 10 events for Wockhardt Usa Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 12 Jan 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.