Reported Oct 22, 2014 · Terminated

Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach,…

Valeant Pharmaceuticals North America LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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: Valeant Pharmaceuticals North America LLC · 400 Somerset Corporate Blvd · Bridgewater, NJ · 08807

Is this the product you have?

  • Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct - NDC 0187-0140-90 5 mg 30 ct - NDC 0187-0141-30 5 mg 90 ct - NDC 0187-0141-90 10 mg 30 ct - NDC 0187-0142-30 10 mg 90 ct - NDC 0187-0142-90 10 mg 1000 ct - NDC 0187-0142-10 20 mg 30 ct - NDC 0187-0143-30 20 mg 90 ct - NDC 0187-0143-90 20 mg 1000 ct - NDC 0187-0143-10 NDC #'s 64455-140, 64455-141, 64455-142 and 64455-143, 30 ct. bottles, 90 ct. bottles and 1000 ct. bottles
Lot codes and dates
  • VASOTEC 2.5MG TAB 30CT 12K015P exp. 9/30/2014 VASOTEC 2.5MG TAB 30CT 13G048P exp. 07/31/2015 VASOTEC 2.5MG TAB 30CT 14A065P exp. 07/31/2015 VASOTEC 2.5MG TAB 90CT 13G020P exp. 07/31/2015 VASOTEC 2.5MG TAB 90CT 12K020P exp. 9/30/2014 VASOTEC 2.5MG TAB 90CT 13B016P exp. 9/30/2014 VASOTEC 5MG TAB 30CT 13B022P exp. 2/28/2015 VASOTEC 5MG TAB 30CT 13B023P exp. 2/28/2015 VASOTEC 5MG TAB 30CT 13C015P exp. 02/28/2015 VASOTEC 5MG TAB 30CT 13E002P exp. 02/28/2015 VASOTEC 5MG TAB 30CT 14A002P exp. 11/30/2015 VASOTEC 5MG TAB 30CT 13L066P exp. 11/30/2015 VASOTEC 5MG TAB 90CT 13B018P exp. 2/28/2015 VASOTEC 5MG TAB 90CT 13G015P exp. 06/30/2015 VASOTEC 10MG TAB 90CT 12M017P exp. 11/30/2014 VASOTEC 10MG TAB 1000CT 12L105P exp. 11/30/2014 VASOTEC 10MG TAB 30CT 12M016P exp. 11/30/2014 VASOTEC 10MG TAB 30CT 13G013P exp. 06/30/2015 VASOTEC 10MG TAB 30CT 13J081P exp. 9/30/2015 VASOTEC 10MG TAB 90CT 12M025P exp. 11/30/2014 VASOTEC 10MG TAB 90CT 13J082P exp. 0/2015 VASOTEC 10MG TAB 90CT 13J085P exp. 0/2015 VASOTEC 10MG TAB 90CT 13J094P exp. 09/30/2015 VASOTEC 10MG TAB 1000CT 13J098P exp. 09/30/2015 VASOTEC 10MG TAB 1000CT 13G011P exp. 06/30/2015 VASOTEC 10MG TAB 1000CT 13J097P exp. 09/30/2015 VASOTEC 20MG TAB 30CT 12J017P exp. 5/31/2014 VASOTEC 20MG TAB 30CT 13C016P exp. 2/28/2015 VASOTEC 20MG TAB 30CT 13E003P exp. 02/28/2015 VASOTEC 20MG TAB 30CT 13L068P exp. 09/30/2015 VASOTEC 20MG TAB 90CT 13J086P exp. 09/30/2015 VASOTEC 20MG TAB 90CT 13J087P exp. 09/30/2015 VASOTEC 20MG TAB 90CT 12M029P exp. 11/30/2014 VASOTEC 20MG TAB 90CT 12M030P exp. 11/30/2014 VASOTEC 20MG TAB 1000CT 12J023P exp. 5/31/2014 VASOTEC 20MG TAB 1000CT 12L108P exp. 11/30/2014 VASOTEC 20MG TAB 1000CT 13C088P exp. 02/28/2015 VASOTEC 20MG TAB 1000CT 13J099P exp. 09/30/2015 VASOTEC 20MG TAB 1000CT 13M054P exp. 09/30/2015 VASOTEC 20MG TAB 1000CT 13M055P exp. 12/31/2015 VASOTEC 20MG TAB 1000CT 14B054P exp. 12/31/2015
Amount recalled
205,853 bottles

This recall covers 2 products

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

Where it was sold

  • Nationwide

Why it was recalled

Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

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 Aug 4, 2015 · Data as of Sep 19, 6:34 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.