CLASS III Drug recall · Reported 22 Oct 2014 · FDA Enforcement Report
Vasotec (enalapril maleate) tablets recalled
Valeant Pharmaceuticals North America is recalling Vasotec (enalapril maleate) tablets, distributed nationwide in the US. The recall was initiated on 21 May 2014 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0019-2015
- FDA event ID
- 68572
- Recalling firm
- Valeant Pharmaceuticals North America, Bridgewater, NJ
- Brand
- Vasotec
- Manufacturer
- Bausch Health US LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 May 2014
- FDA classified
- 10 Oct 2014
- Reported
- 22 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Blood Pressure Medication
Timeline
| 21 May 2014 | Recall initiated by company | |
| 10 Oct 2014 | Classified by FDA | +142 days |
| 22 Oct 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Which lots are affected?
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
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 68572This product is part of a recall event; the main page for the event is Vaseretic (enalapril maleate/hydrochlorothiazide) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Vaseretic (enalapril maleate/hydrochlorothiazide) recalledVaseretic | Valeant Pharmaceuticals North America | Packaging Defects | Nationwide |
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|---|---|---|---|---|---|
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|---|---|---|---|---|---|
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| Drug | CLASS II | Enalapril Maleate Tablets recalled by Golden State Medical SupplyEnalapril Maleate | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Enalapril Maleate Tablets recalled by Golden State Medical SupplyEnalapril Maleate | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Enalapril Maleate Tablets recalled by Golden State Medical SupplyEnalapril Maleate | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |