Enalapril Maleate 5mg Tablets (Major Pharmaceuticals) – impurity specifications (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 Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, 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; Distributed by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152; NDC 0904-5502-61.
Brand
MAJOR PHARMACEUTICALS
Lot Codes / Batch Numbers
Lot #: T-01082, Exp 08/18, DR10445A, Exp 09/18, DR10443A, Exp 12/18, DR10445B, Exp 03/19, DR10725A, Exp 07/19, DS10024A, DS10040A, Exp 10/19.
Products Sold
Lot #: T-01082, Exp 08/18; DR10445A, Exp 09/18; DR10443A, Exp 12/18; DR10445B, Exp 03/19; DR10725A, Exp 07/19; DS10024A, DS10040A, Exp 10/19.
MAJOR PHARMACEUTICALS is recalling Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactu due to Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out. 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
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
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