Class III · Lower riskRecall completed
Enalapril Maleate tablets
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot # DR10635, EXP 05/2019; DR10636, EXP 05/2019.
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byWockhardt 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 foreign manufacturer
| Distributed by / for | Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA |
| NDC | 64679-924-03 |
Show the full FDA record
| Full product label | 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; |
| Recalling firm | Wockhardt Usa Inc. |
| Distribution | Nationwide in the USA |
| Quantity | 5050 bottles |
| Recall initiated | 2017-08-22 |
| Report date | 2017-11-01 |
| Recall completed | 2019-02-27 |
| Recall number | D-0051-2018 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Parsippany NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.