CLASS II Drug recall · Reported 15 Jul 2015 · FDA Enforcement Report
Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg recalled
Apotex is recalling Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, distributed nationwide in the US. The recall was initiated on 29 May 2015 and the FDA has classified it as Class II.
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-1215-2015
- FDA event ID
- 71418
- Recalling firm
- Apotex, Toronto, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 May 2015
- FDA classified
- 7 Jul 2015
- Reported
- 15 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 29 May 2015 | Recall initiated by company | |
| 7 Jul 2015 | Classified by FDA | +39 days |
| 15 Jul 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Product as listed by the FDA
Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India, NDC 60505-0209-1
Where it was distributed
Nationwide, Hawaii and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Which lots are affected?
Lot #: KP4529, Exp 10/2015
Where was it sold?
Nationwide, Hawaii and Puerto Rico
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
3 other products · FDA event 71418| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Losartan potassium tablets USP, 25 mg recalled by Apotex | Apotex | Other | Nationwide | |
| CLASS II | Losartan potassium tablets USP, 100 mg recalled by Apotex | Apotex | Other | Nationwide | |
| CLASS II | Losartan potassium tablets USP, 50 mg recalled by Apotex | Apotex | Other | Nationwide |
More recalls from Apotex
All 75| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled | Apotex | Other | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | 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 |