The Recall Desk
LowFDA (Drugs)·D-0051-2018·Announced 2017-11-01

Wockhardt Recalls Enalapril Maleate Tablets Due to Impurity Failures

Wockhardt USA is recalling 5mg Enalapril Maleate tablets because they failed impurity specifications. The recall covers 5,050 bottles distributed nationwide.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Wockhardt USA Inc. is recalling 5,050 bottles of Enalapril Maleate tablets, USP, 5mg, 1000-count. The product is prescription-only and was distributed nationwide in the United States. The specific lots affected are DR10635 and DR10636, both with an expiration date of 05/2019.

The recall was initiated because the 5mg strength tablets failed impurity and degradation specifications. Specifically, the products yielded out-of-specification results for related compounds. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Patients and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or distributor for disposal or replacement.

The recalled product

Product
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;
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
5,050

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot # DR10635
  • EXP 05/2019
  • DR10636
  • EXP 05/2019.

Distribution

Distributed nationwide across the United States.

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Same hazard · impurity

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