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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The source text does not report any illnesses or injuries.
Plain-English summary
Wockhardt Limited is voluntarily recalling 17,628 tablets of Enalapril Maleate Tablets USP, 2.5 mg. 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 impurities and degradation specifications. The affected batches are DR10447 (Exp: 4/19), DR10996 (Exp: 10/19), DS10201 (Exp: 2/20), and DR10319 (Exp: 3/20). The NDC code for the product is 64679-923-03.
The product was distributed nationwide. Consumers and healthcare providers should check their inventory for these specific batch numbers and expiration dates. If the product is found, it should be returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 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
- Affected units
- 17,628
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)
- Batch# DR10447 (Exp: 4/19)
- Batch# DR10996 (Exp: 10/19)
- Batch# DS10201 (Exp: 2/20)
- and Batch# DR10319 (Exp: 3/20).
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 →Related recalls
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See all →- ModerateWockhardt Recalls Enalapril Maleate Tablets Due to Impurity Failures
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