The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1180-2022·Announced 2022-07-13

Prescription Drug Recall: Enalapril Maleate Due to Manufacturing Deviations

Golden State Medical Supply Inc. is recalling 1,424 bottles of Enalapril Maleate 20 mg tablets due to Current Good Manufacturing Practice deviations. The affected lot numbers have expiration dates ranging from March 2022 to December 2022.

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 voluntary precautionary recall for manufacturing compliance deviations with no reported illnesses or injuries. The hazard is theoretical, fitting the rubric criterion for 'voluntary precautionary recalls' at severity score 2.

Plain-English summary

Golden State Medical Supply Inc. is recalling Enalapril Maleate Tablets, USP 20 mg, distributed nationwide to customers in Pennsylvania, Massachusetts, Ohio, Texas, Illinois, North Dakota, and Hawaii. Approximately 1,424 bottles with NDC 60429-186-90 are affected, manufactured by Taro Pharmaceutical Industries, Ltd.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. This voluntary recall was initiated by the firm on March 16, 2022, and the FDA classified it as a Class II recall on July 7, 2022.

The affected lot numbers and expiration dates are: GS035031 and GS035199 (expires 03/2022), GS036495 and GS036904 (expires 05/2022), GS037401 (expires 09/2022), GS037986, GS038359, and GS039560 (expires 11/2022), and GS041110 (expires 12/2022).

No illnesses or injuries have been reported in connection with this recall. The recall status remains ongoing.

The recalled product

Product
ENALAPRIL MALEATE (ENALAPRIL MALEATE)
Brand
ENALAPRIL MALEATE
Manufacturer
Golden State Medical Supply Inc.
Category
Drug
Hazard
Affected units
1,424

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 (16)

  • Lots: GS035031
  • GS035199
  • 20 mg
  • 90 tablets
  • Exp.: 03/2022
  • Lots: GS036495
  • GS036904
  • Exp.: 05/2022
  • Lots: GS037401
  • Exp.: 09/2022
  • Lots: GS037986
  • GS038359
  • GS039560
  • Exp.: 11/2022
  • Lot: GS041110
  • Exp.: 12/2022. (NDC: 60429-186-90).

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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