MAJOR PHARMACEUTICALS recalls Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt
MAJOR PHARMACEUTICALS recalls 5mg Enalapril Maleate tablets due to impurity issues. Affected lots from 2023-2019; stop using if you have these specific lot numbers.
Recall notice
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.
Contact the company & request your remedy
What happened, in plain English
MAJOR PHARMACEUTICALS is recalling 5mg Enalapril Maleate tablets that may contain harmful impurities. This affects specific batches produced between 2019 and 2023. If you have these tablets, they should be stopped using immediately. Read more at govinfonow.com/recall/40396-major-pharmaceuticals-enalapril-5mg-tablets-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40396-major-pharmaceuticals-enalapril-5mg-tablets-recall-impurity-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-0980-2018
Cite this page
“MAJOR PHARMACEUTICALS Enalapril 5mg Tablets Recall: Impurity Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40396-major-pharmaceuticals-enalapril-5mg-tablets-recall-impurity-risk. Based on FDA recall #D-0980-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0980-2018%22&limit=1).
Why it’s dangerous
The tablets may contain a degradation product called Enalapril DiKetopiperazine, which can be harmful if consumed. This impurity was detected during quality testing and falls outside safe manufacturing standards.
Who’s affected
People with prescriptions for Enalapril 5mg tablets from the listed lot numbers. Those with high blood pressure or heart conditions are most at risk.
How to tell if you have this one
Check the lot number on the tablet packaging. Affected lots include T-01082 (exp 08/18), DR10445A (exp 09/18), DR10443A (exp 12/18), DR10445B (exp 03/19), DR10725A (exp 07/19), DS10024A and DS10040A (exp 10/19).
- Brand
MAJOR PHARMACEUTICALS- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide in the USA and Puerto Rico.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0979-2018 | Enalapril Maleate Tablets, USP, 2.5 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 0904-5609-61.; Lot #: T-01083, Exp 08/18; DR10447A, Exp 09/18; DS10201A, Exp 07/19; DS10201B, DS10201C, Exp 08/19; DS10319A, Exp 10/19. | 3,397 cartons |
| D-0980-2018 | 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.; 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. | 5,933 cartons |
What to do — step by step
Check Lot Number
Look for the lot number on the tablet packaging to determine if it's affected.
Stop Using Tablets
If you have affected lot numbers, stop using the tablets immediately.
Questions people ask
Why is this product being recalled?
The tablets may contain harmful impurities called Enalapril DiKetopiperazine, which was detected during quality testing and falls outside safe manufacturing standards.
Which lot numbers are affected?
Affected lots include T-01082 (exp 08/18), DR10445A (exp 09/18), DR10443A (exp 12/18), DR10445B (exp 03/19), DR10725A (exp 07/19), and DS10024A/DS10040A (exp 10/19).
How do I know if I have the affected product?
Check the lot number on the tablet packaging. The affected lots are listed in the recall notice.
Contact MAJOR PHARMACEUTICALS
We’ve drafted a message you can send MAJOR PHARMACEUTICALS to request your refund or repair — edit it as you like.
Subject: Recall D-0980-2018 — MAJOR PHARMACEUTICALS MAJOR PHARMACEUTICALS Hello, I own a MAJOR PHARMACEUTICALS that is covered by recall D-0980-2018 from MAJOR PHARMACEUTICALS. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0980-2018 (June 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0980-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.