The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1177-2022·Announced 2022-07-13

Prescription drug Enalapril Maleate recalled for manufacturing deviations

Golden State Medical Supply Inc. is recalling Enalapril Maleate 2.5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations. Approximately 1,471 bottles were 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: FDA Class II recall with voluntary firm initiation and no reported illnesses or injuries. CGMP deviations represent manufacturing quality control issues without confirmed patient harm.

Plain-English summary

Enalapril Maleate Tablets, USP 2.5 mg (NDC 60429-183-90) are being recalled by Golden State Medical Supply Inc. The product was manufactured by Taro Pharmaceutical Industries, Ltd., and packaged by Golden State Medical Supply Inc. in California. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations.

Approximately 1,471 bottles are affected by this Class II recall. The affected product was distributed nationwide to patients in Pennsylvania, Massachusetts, Ohio, Texas, Illinois, North Dakota, and Hawaii. Multiple lot numbers are affected, with expiration dates ranging from June 2022 through November 2023. Specific lot information and expiration dates are documented in FDA recall notice D-1177-2022.

No illnesses or injuries have been reported in connection with this recall. Golden State Medical Supply Inc. voluntarily initiated the recall on March 16, 2022.

Patients or healthcare providers who have this medication should contact their pharmacy to determine if they have affected product. Patients should not discontinue their medication without consulting their healthcare provider. Healthcare providers can advise on appropriate next steps, including whether an alternative medication is needed.

The recalled product

Product
ENALAPRIL MALEATE (ENALAPRIL MALEATE)
Brand
ENALAPRIL MALEATE
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription
Hazard
Affected units
1,471

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: GS028301
  • 2.5 mg
  • 90 tablets
  • Exp.: 06/2022
  • Lots: GS029973
  • GS029974
  • GS031436
  • GS031715
  • GS033191
  • GS033940
  • Exp. : 10/2022
  • Lot: GS034212
  • Exp.: 12/2022
  • Lot: GS035315
  • GS035945
  • GS036905
  • GS038038
  • GS039199
  • Exp.: 04/2023
  • Lot: GS039200

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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