CLASS III Drug recall · Reported 22 Oct 2014 · FDA Enforcement Report
Vaseretic (enalapril maleate/hydrochlorothiazide) recalled
Valeant Pharmaceuticals North America is recalling Vaseretic (enalapril maleate/hydrochlorothiazide) 10, 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-0018-2015
- FDA event ID
- 68572
- Recalling firm
- Valeant Pharmaceuticals North America, Bridgewater, NJ
- Brand
- Vaseretic
- 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 outset
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
Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada
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 outset
Which lots are affected?
VASERETIC 10-25MG TAB 100CT Lot # 12J022P exp. 9/30/2014 VASERETIC 10-25MG TAB 100CT Lot # 13G047P exp. 07/31/2015
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 68572| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Vasotec (enalapril maleate) tablets recalledVasotec | Valeant Pharmaceuticals North America | Packaging Defects | Nationwide |
More recalls from Valeant Pharmaceuticals North America
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 240 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 180 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 300 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Diltiazem HCl CD capsules, 360 mg recalled | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 120 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
Other Enalapril recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Enalapril Maleate Tablets, USP, 20 mg recalled by JB Chemicals andEnalapril Maleate | JB Chemicals and Pharmaceuticals | Potency & Assay | 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 |
| 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 |