The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1178-2022·Announced 2022-07-13

Enalapril Maleate Tablets Recalled Due to Manufacturing Practice Deviations

Golden State Medical Supply Inc. is recalling Enalapril Maleate Tablets due to manufacturing practice deviations. The voluntary recall involves 9,058 units distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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: This is a Class II recall initiated voluntarily by the firm for manufacturing practice deviations. No illnesses or injuries have been reported, and the hazard is theoretical rather than a confirmed product defect, meeting the rubric criterion for voluntary precautionary recalls.

Plain-English summary

Enalapril Maleate Tablets, USP, 5 mg, packaged in bottles of 90 tablets, are being recalled by Golden State Medical Supply Inc. in a voluntary, firm-initiated recall. The recall involves 9,058 units manufactured by Taro Pharmaceutical Industries, Ltd., and packaged by Golden State Medical Supply, Inc., based in Camarillo, California.

The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. As of the report date of July 13, 2022, no illnesses or injuries have been reported in connection with this product.

The affected product was distributed nationwide to pharmacies and consumers in Pennsylvania, Massachusetts, Ohio, Texas, Illinois, North Dakota, and Hawaii. Multiple lot numbers are affected with varying expiration dates through March 2024.

Consumers who have this medication should check the lot number against the FDA's recall list (D-1178-2022). Those with affected batches should contact their pharmacy or healthcare provider for guidance on whether to continue use or obtain a replacement from an unaffected lot.

The recalled product

Product
ENALAPRIL MALEATE (ENALAPRIL MALEATE)
Brand
ENALAPRIL MALEATE
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Antihypertensive
Hazard
Affected units
9,058

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 (20)

  • Lot: GS029041
  • GS029353
  • GS02986
  • 5 mg
  • 90 tablets
  • Exp.: 09/2022
  • Lot: GS030056
  • GS030869
  • GS033943
  • Exp.: 10/2022
  • Lots: GS034490
  • GS035197
  • Exp.:02/2023
  • Lots: GS035198
  • Exp.: 03/2023
  • Lots: GS035596
  • GS035947
  • GS036759
  • GS037400
  • Exp.: 06/2023

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Golden State Medical Supply Inc. 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 4 products in this recall →

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