The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1179-2022·Announced 2022-07-13

FDA Recalls Enalapril Maleate Tablets Over Manufacturing Practice Deviations

Golden State Medical Supply is recalling 31,260 bottles of Enalapril Maleate Tablets due to manufacturing practice deviations.

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 an FDA Class II recall with no reported illnesses or injuries. The hazard is manufacturing practice deviations rather than a direct health threat. The voluntary nature and absence of harm reports support a Moderate severity rating.

Plain-English summary

Enalapril Maleate Tablets, USP, 10 mg in 90-tablet bottles are being recalled by packager Golden State Medical Supply Inc. (GSMS) of Camarillo, California. The product was manufactured by Taro Pharmaceutical Industries, Ltd. The recall affects 31,260 bottles with lot numbers ranging from GS027890 through GS041656, with expiration dates from April 2022 through May 2024.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during regulatory review. No illnesses or injuries have been reported in connection with this product.

The affected product was distributed nationwide to patients in Pennsylvania, Massachusetts, Ohio, Texas, Illinois, North Dakota, and Hawaii. Healthcare providers and patients who have received affected lots should take action immediately.

Stop using affected lots and contact Golden State Medical Supply Inc. for instructions on return or replacement. Patients should consult their healthcare provider about obtaining an unaffected alternative to continue their blood pressure medication.

The recalled product

Product
ENALAPRIL MALEATE (ENALAPRIL MALEATE)
Brand
ENALAPRIL MALEATE
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription
Hazard
Affected units
31,260

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)

  • Lots: GS027890
  • GS028177
  • GS028488
  • 10 mg
  • 90 tablets
  • Exp.: 04/2022
  • Lots: GS028847
  • GS028848
  • Exp.: 09/2022
  • GS029627
  • GS029862
  • GS030057
  • GS030481
  • GS030870
  • GS031060
  • GS031437
  • GS031438
  • GS033527
  • GS034231
  • Exp.: 10/2022

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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