Reported Jul 29, 2015 · Terminated

Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited,…

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?

  • Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only
  • Manufactured byWockhardt Limited, Mumbai, India
  • Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
  • NDC64679-421-01
Lot codes and dates

13 of 13 products

Products covered by this recall
#Product as published
1DM11774, Expiry: 6/30/2015
2Lot #: DM13056, Expiry: 10/31/2015
3Lot #: DM13117, Expiry: 10/31/2015
4Lot #: DM13159, Expiry: 10/31/2015
5Lot #: DM13186, Expiry: 10/31/2015
6Lot #: DM13187, Expiry: 10/31/2015
7Lot #: DM13188, Expiry: 10/31/2015
8Lot #: DN10003, Expiry: 11/30/2015
9Lot #: DN10045, Expiry: 11/30/2015
10Lot #: DN10046, Expiry: 11/30/2015
11Lot #: DN10389, Expiry: 1/31/2016
12Lot #: DN10412, Expiry: 1/31/2016
13Lot #: DN10604, Expiry: 1/31/2016.
Amount recalled
124,034 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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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, 7:21 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.