Enalapril Maleate 5mg 90-count (Aidarex) – degradation product (2018)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90
Brand
Aidarex Pharmaceuticals LLC
Lot Codes / Batch Numbers
Lots: 51904-1, EXP: 01/31/2018, 51904-4, 52885-1, EXP: 03/31/2018, 52885-3, EXP: 04/30/2018, 52885-4, EXP: 05/28/2018, 53840-2, EXP: 5/28/2018, 53840-3, EXP:6/30/2018, 53840-4, EXP:8/31/2018, 56665-1, EXP: 01/31/2019, 58596-1, EXP: 05/28/2019.
Products Sold
Lots: 51904-1, EXP: 01/31/2018; 51904-4, 52885-1, EXP: 03/31/2018; 52885-3, EXP: 04/30/2018; 52885-4,EXP: 05/28/2018; 53840-2,EXP: 5/28/2018; 53840-3, EXP:6/30/2018; 53840-4, EXP:8/31/2018; 56665-1, EXP: 01/31/2019; 58596-1, EXP: 05/28/2019.
Aidarex Pharmaceuticals LLC is recalling Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Woc due to Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026