RecallRadar

FDA Drug recall D-0912-2018

Enalapril Maleate Tablets USP

On 2018-07-18 the FDA classified a Class III recall of Enalapril Maleate Tablets USP by Wockhardt, citing failed Impurities/Degradation Specifications.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0912-2018
ClassificationClass III
Statusterminated
Initiated2018-06-19
Published2018-07-18
Last updated2026-09-13 11:52 UTC
CompanyWockhardt
DistributionUS

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.

Reason

Failed Impurities/Degradation Specifications

Identifiers

code_info
Batch# DR10445 (Exp: 4/19); Batch# DR10637 (Exp: 5/19); Batch# DR10646 (Exp: 5/19); Batch# DR10647 (Exp: 5/19); Batch#…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).

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0912-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.