Major Pharmaceuticals Recalls Enalapril Maleate Tablets Due to Impurities
Major Pharmaceuticals recalls Enalapril Maleate 5mg tablets due to failed impurity specifications. Check your lot numbers and expiration dates for affected units.
Use caution until it’s fixed
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.
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What happened, in plain English
Major Pharmaceuticals is recalling Enalapril Maleate Tablets, USP, 5 mg because the product contains out-of-specification levels of a degradation product called Enalapril DiKetopiperazine. This sub-recall was initiated after the manufacturing firm, Wockhardt, identified these issues. The affected tablets were distributed nationwide in the USA and Puerto Rico. Read more at govinfonow.com/recall/40396-major-pharmaceuticals-recalls-enalapril-maleate-tablets-due-to-impurities.
Source Summary by GovInfoNow · govinfonow.com/recall/40396-major-pharmaceuticals-recalls-enalapril-maleate-tablets-due-to-impurities · Updated October 11, 2026 · FDA enforcement record: FDA #D-0980-2018
Cite this page
“Major Pharmaceuticals Recalls Enalapril Maleate Tablets Due to Impurities.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/40396-major-pharmaceuticals-recalls-enalapril-maleate-tablets-due-to-impurities. 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 failed impurity specifications due to elevated levels of Enalapril DiKetopiperazine, a degradation product. While the record classifies this as a Class III recall (typically associated with products unlikely to cause adverse health consequences), the presence of out-of-specification impurities means the drug's quality and stability are compromised.
Who’s affected
Patients who have been prescribed Enalapril Maleate Tablets, USP, 5 mg by a healthcare provider. Individuals who purchased or possess the specific lots listed below are at risk of receiving product that does not meet purity specifications.
How to tell if you have this one
Look for Enalapril Maleate Tablets, USP, 5 mg, distributed by Major Pharmaceuticals. Check the NDC 0904-5502-61 on the 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), and DS10024A/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 Your Medication
Verify if your Enalapril Maleate Tablets match the NDC and lot numbers listed in the recall details.
Contact Your Pharmacist
If you have the recalled product, contact your pharmacist or healthcare provider for instructions on replacement or disposal.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How many cartons are being recalled?
Approximately 5,933 cartons of Enalapril Maleate Tablets, USP, 5 mg are included in this recall.
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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 qwen3.6:35b-a3b on October 11, 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.