Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0912-2018·Announced 2018-07-18

Wockhardt Recalls Enalapril Maleate Tablets Due to Impurity Failures

Wockhardt Limited is recalling specific batches of Enalapril Maleate Tablets USP because they failed impurity and degradation specifications.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard involves failed impurity specifications without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Wockhardt Limited is recalling 31,710 tablets of Enalapril Maleate Tablets USP, 5 mg (NDC code 64679-924-03). The affected product is packaged in 1000-tablet HDPE containers with non-CRC caps and two desiccants, further packed in E-flute cartons.

The recall was initiated because the product failed impurity and degradation specifications. The affected batches include DR10445, DR10637, DR10646, DR10647, DR10725, DR10755, DR10811, DS10040, DS10041, DS10024, and DS10048, with expiration dates ranging from April 2019 to December 2019.

The product was distributed nationwide. Consumers and healthcare providers should check their inventory for these specific batch numbers and stop using the product if it matches the recalled description.

The recalled product

Product: Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
Manufacturer: Wockhardt Limited
Category: Drug — Prescription Medication
Hazard: impurity
degradation
Affected units: 31,710

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 (11)

Batch# DR10445 (Exp: 4/19)
Batch# DR10637 (Exp: 5/19)
Batch# DR10646 (Exp: 5/19)
Batch# DR10647 (Exp: 5/19)
Batch# DR10725 (Exp: 7/19)
Batch# DR10755 (Exp: 7/19)
Batch# DR10811 (Exp: 9/19)
Batch# DS10040 (Exp: 12/19)
Batch# DS10041 (Exp: 12/19)
Batch# DS10024 (Exp: 12/19)
and Batch# DS10048 (Exp: 12/19).

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Wockhardt Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Wockhardt Limited

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Low
Wockhardt Recalls Enalapril Maleate Tablets Due to Impurity Failures
FDA (Drugs) · 2018-07-18

Same hazard · impurity