Class II · Moderate risk
Enalapril Maleate Tablets
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Enalapril Maleate tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03;
Affected NDC
64679-0924-03
Compare with the code on your package — it is the most precise check available.
Drug: Enalapril Category: Blood Pressure Medication
- Recalling firm
- Wockhardt Usa Inc.
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0051-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Enalapril recalls
See all
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations
Other recalls by Wockhardt Usa Inc.
All 2017 recalls
Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specifications
Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
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