The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0979-2018·Announced 2018-08-01

Major Pharmaceuticals Recalls Enalapril Maleate Tablets Due to Impurities

Major Pharmaceuticals is recalling specific lots of Enalapril Maleate Tablets, 2.5 mg, because the product failed impurity specifications for a degradation product.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard involves failed impurity specifications without reported illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Major Pharmaceuticals is recalling 3,397 cartons of Enalapril Maleate Tablets, USP, 2.5 mg. The product is distributed nationwide in the USA and Puerto Rico. The recall is a sub-recall initiated because the manufacturing firm, Wockhardt, identified out-of-specification results for the Enalapril DiKetopiperazine degradation product.

The affected lots are T-01083 (Exp 08/18), DR10447A (Exp 09/18), DS10201A (Exp 07/19), DS10201B (Exp 08/19), DS10201C (Exp 08/19), and DS10319A (Exp 10/19). The tablets are manufactured by Wockhardt Limited and distributed by Wockhardt USA LLC and Major Pharmaceuticals.

Consumers should check their medication for these specific lot numbers and expiration dates. If the product matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.

The recalled product

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…
Manufacturer
MAJOR PHARMACEUTICALS
Category
Drug — Prescription Medication
Hazard
Affected units
3,397

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • Lot #: T-01083
  • Exp 08/18
  • DR10447A
  • Exp 09/18
  • DS10201A
  • Exp 07/19
  • DS10201B
  • DS10201C
  • Exp 08/19
  • DS10319A
  • Exp 10/19.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by MAJOR PHARMACEUTICALS under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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