Reported Jul 29, 2015 · Terminated

Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles…

Wockhardt USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Wockhardt Usa Inc. · 20 Waterview Blvd Ste 3 · Parsippany, NJ · 07054-1271

Is this the product you have?

  • Captopril Tablets, USP, 50 mg Tablets
  • Packaged in A) 100 Count Bottles (NDC64679-0904-01)
  • and B) 1000 Count Bottles (NDC64679-0904-02), Rx only
  • Manufactured byWockhardt Limited, Mumbai, India
  • Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
Lot codes and dates

36 of 36 products

Products covered by this recall
#Product as published
1LM11093, Expiry: 6/30/2015
2Lot #: LM11335, Expiry: 7/31/2015
3Lot #: LM11336, Expiry: 7/31/2015
4Lot #: LM11461, Expiry: 8/31/2015
5Lot #: LM11462, Expiry: 8/31/2015
6Lot #: LM11579, Expiry: 8/31/2015
7Lot #: LM11778, Expiry: 9/30/2015
8Lot #: LM11995, Expiry: 11/30/2015
9Lot #: LN10029, Expiry: 11/30/2015
10Lot #: LN10071, Expiry: 12/31/2015
11Lot #: LN10349, Expiry: 1/31/2016
12Lot #: LN10350, Expiry: 1/31/2016
13Lot #: LN10505, Expiry: 2/29/2016
14Lot #: LN10506, Expiry: 2/29/2016
15Lot #: LN10814, Expiry: 3/31/2016
16Lot #: LN10815, Expiry: 3/31/2016
17Lot #: LN10977, Expiry: 4/30/2016
18Lot #: LN11156, Expiry: 6/30/2016
19Lot #: LN11260, Expiry: 7/31/2016. B) Lot #: LM10643, Expiry: 4/30/2015
20Lot #: LM10846, Expiry: 5/31/2015
Amount recalled
A) 216,329 Bottles and B) 18,514 Bottles.

This recall covers 35 products

The agency filed one notice per product. You are reading one of them; the other 34 are below.

22 more are in the archive.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

CGMP Deviations: Firm did not adequately investigate customer complaints.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 9, 2018 · Data as of Sep 19, 7:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.