Reported May 13, 2015 · Terminated

Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02,…

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 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India
  • Distributed byWockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA
Lot codes and dates

12 of 12 products

Products covered by this recall
#Product as published
1LM10525, Exp 03/15
2LM10727, Exp 04/15
3LM11519, Exp 08/15
4LN10008, Exp 11/15
5LN10121, Exp 12/15
6LN10887, Exp 04/16
7LM11248, Exp 06/16 Lot #s: b) LM10522, Exp 03/15
8LM10726, Exp 04/15
9LN10007, Exp 11/15
10LN10116, Exp 12/15
11LN10888, Exp 04/16
12LN11281 Exp 07/16
Amount recalled
93,393 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Tablet/Capsule Specifications: out of specification for thickness.

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 Dec 14, 2017 · Data as of Sep 19, 7:13 PM UTC

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