# FDA recall D-0979-2018

> **MAJOR PHARMACEUTICALS** · Class III · drug recall initiated 2018-06-26.

## Product

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.

## Reason for recall

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.

## Distribution

Nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-0979-2018
- **Recalling firm:** MAJOR PHARMACEUTICALS
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-06-26
- **Report date:** 2018-08-01
- **Termination date:** 2019-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Livonia, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0979-2018

## Citation

> AI Analytics. FDA recall D-0979-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0979-2018. Source: US FDA. Licensed CC0.

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