Medications & Supplements/Prescription Drugs

GSMS Enalapril Maleate Tablets Recalled for Manufacturing Practice Deviations

Agency Publication Date: July 7, 2022

Summary

Golden State Medical Supply Inc. is recalling 43,213 bottles of Enalapril Maleate Tablets, USP, in 2.5 mg, 5 mg, 10 mg, and 20 mg strengths. Enalapril Maleate is a medication used to treat high blood pressure. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations discovered at the manufacturing facility. Each bottle contains 90 tablets and was distributed nationwide to specific states including PA, MA, OH, TX, IL, ND, and HI.

Risk

Failure to follow Good Manufacturing Practices can lead to drugs that do not meet quality, safety, and purity standards. This may result in medication that is less effective or potentially unsafe for patients.

What You Should Do

This recall affects Enalapril Maleate Tablets, USP, in 2.5 mg, 5 mg, 10 mg, and 20 mg strengths sold in 90-count bottles under the Golden State Medical Supply label.
Check your bottle for National Drug Codes (NDC) 60429-183-90 (2.5 mg), 60429-184-90 (5 mg), 60429-185-90 (10 mg), or 60429-186-90 (20 mg).
Verify the lot number and expiration date on your packaging. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Golden State Medical Supply Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or wish to report a concern.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Enalapril Maleate Tablets, USP (2.5 mg, 90 tablets)

Variants: 2.5 mg, 90 tablets

Lot Numbers:

GS028301 (Exp 06/2022)

GS029973 (Exp 10/2022)

GS029974 (Exp 10/2022)

GS031436 (Exp 10/2022)

GS031715 (Exp 10/2022)

GS033191 (Exp 10/2022)

GS033940 (Exp 10/2022)

GS034212 (Exp 12/2022)

GS035315 (Exp 04/2023)

GS035945 (Exp 04/2023)

GS036905 (Exp 04/2023)

GS038038 (Exp 04/2023)

GS039199 (Exp 04/2023)

GS039200 (Exp 11/2023)

GS040149 (Exp 11/2023)

NDC:

60429-183-90

Manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA, USA.

Product: Enalapril Maleate Tablets, USP (5 mg, 90 tablets)

Variants: 5 mg, 90 tablets

Lot Numbers:

GS029041 (Exp 09/2022)

GS029353 (Exp 09/2022)

GS02986 (Exp 09/2022)

GS030056 (Exp 10/2022)

GS030869 (Exp 10/2022)

GS033943 (Exp 10/2022)

GS034490 (Exp 02/2023)

GS035197 (Exp 02/2023)

GS035198 (Exp 03/2023)

GS035596 (Exp 06/2023)

GS035947 (Exp 06/2023)

GS036759 (Exp 06/2023)

GS037400 (Exp 06/2023)

GS038089 (Exp 10/2023)

GS038763 (Exp 10/2023)

GS039559 (Exp 10/2023)

GS040150 (Exp 10/2023)

GS040151 (Exp 12/2023)

GS040708 (Exp 12/2023)

GS041107 (Exp 12/2023)

GS041654 (Exp 03/2024)

NDC:

60429-184-90

Manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.

Product: Enalapril Maleate Tablets, USP (10 mg, 90 tablets)

Variants: 10 mg, 90 tablets

Lot Numbers:

GS027890 (Exp 04/2022)

GS028177 (Exp 04/2022)

GS028488 (Exp 04/2022)

GS028847 (Exp 09/2022)

GS028848 (Exp 09/2022)

GS029627 (Exp 10/2022)

GS029862 (Exp 10/2022)

GS030057 (Exp 10/2022)

GS030481 (Exp 10/2022)

GS030870 (Exp 10/2022)

GS031060 (Exp 10/2022)

GS031437 (Exp 10/2022)

GS031438 (Exp 10/2022)

GS033527 (Exp 10/2022)

GS034231 (Exp 10/2022)

GS034810 (Exp 01/2023)

GS035240 (Exp 05/2023)

GS035598 (Exp 05/2023)

GS036194 (Exp 06/2023)

GS036760 (Exp 08/2023)

GS036981 (Exp 08/2023)

GS037526 (Exp 08/2023)

GS038177 (Exp 08/2023)

GS038728 (Exp 08/2023)

GS038729 (Exp 09/2023)

GS041108 (Exp 09/2023)

GS039412 (Exp 12/2023)

GS039840 (Exp 12/2023)

GS041109 (Exp 12/2023)

GS041655 (Exp 01/2024)

GS041656 (Exp 05/2024)

NDC:

60429-185-90

Manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.

Product: Enalapril Maleate Tablets, USP (20 mg, 90 tablets)

Variants: 20 mg, 90 tablets

Lot Numbers:

GS035031 (Exp 03/2022)

GS035199 (Exp 03/2022)

GS036495 (Exp 05/2022)

GS036904 (Exp 05/2022)

GS037401 (Exp 09/2022)

GS037986 (Exp 11/2022)

GS038359 (Exp 11/2022)

GS039560 (Exp 11/2022)

GS041110 (Exp 12/2022)

NDC:

60429-186-90

Manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89863

Status: Active

Manufacturer: Golden State Medical Supply Inc.

Sold By: Golden State Medical Supply Inc.

Manufactured In: United States

Units Affected: 4 products (1,471 bottles; 9,058; 31,260 bottles; 1,424 bottles)

Distributed To: Pennsylvania, Massachusetts, Ohio, Texas, Illinois, North Dakota, Hawaii

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Enalapril Maleate Tablets, USP, in 2.5 mg, 5 mg, 10 mg, and 20 mg strengths sold in 90-count bottles under the Golden State Medical Supply label.

Check your bottle for National Drug Codes (NDC) 60429-183-90 (2.5 mg), 60429-184-90 (5 mg), 60429-185-90 (10 mg), or 60429-186-90 (20 mg).

Verify the lot number and expiration date on your packaging. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Golden State Medical Supply Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or wish to report a concern.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Enalapril Maleate Tablets, USP (2.5 mg, 90 tablets)

Variants: 2.5 mg, 90 tablets

Lot Numbers:

GS028301 (Exp 06/2022)

GS029973 (Exp 10/2022)

GS029974 (Exp 10/2022)

GS031436 (Exp 10/2022)

GS031715 (Exp 10/2022)

GS033191 (Exp 10/2022)

GS033940 (Exp 10/2022)

GS034212 (Exp 12/2022)

GS035315 (Exp 04/2023)

GS035945 (Exp 04/2023)

GS036905 (Exp 04/2023)

GS038038 (Exp 04/2023)

GS039199 (Exp 04/2023)

GS039200 (Exp 11/2023)

GS040149 (Exp 11/2023)

NDC:

60429-183-90

Manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA, USA.

Product: Enalapril Maleate Tablets, USP (5 mg, 90 tablets)

Variants: 5 mg, 90 tablets

Lot Numbers:

GS029041 (Exp 09/2022)

GS029353 (Exp 09/2022)

GS02986 (Exp 09/2022)

GS030056 (Exp 10/2022)

GS030869 (Exp 10/2022)

GS033943 (Exp 10/2022)

GS034490 (Exp 02/2023)

GS035197 (Exp 02/2023)

GS035198 (Exp 03/2023)

GS035596 (Exp 06/2023)

GS035947 (Exp 06/2023)

GS036759 (Exp 06/2023)

GS037400 (Exp 06/2023)

GS038089 (Exp 10/2023)

GS038763 (Exp 10/2023)

GS039559 (Exp 10/2023)

GS040150 (Exp 10/2023)

GS040151 (Exp 12/2023)

GS040708 (Exp 12/2023)

GS041107 (Exp 12/2023)

GS041654 (Exp 03/2024)

NDC:

60429-184-90

Manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.

Product: Enalapril Maleate Tablets, USP (10 mg, 90 tablets)

Variants: 10 mg, 90 tablets

Lot Numbers:

GS027890 (Exp 04/2022)

GS028177 (Exp 04/2022)

GS028488 (Exp 04/2022)

GS028847 (Exp 09/2022)

GS028848 (Exp 09/2022)

GS029627 (Exp 10/2022)

GS029862 (Exp 10/2022)

GS030057 (Exp 10/2022)

GS030481 (Exp 10/2022)

GS030870 (Exp 10/2022)

GS031060 (Exp 10/2022)

GS031437 (Exp 10/2022)

GS031438 (Exp 10/2022)

GS033527 (Exp 10/2022)

GS034231 (Exp 10/2022)

GS034810 (Exp 01/2023)

GS035240 (Exp 05/2023)

GS035598 (Exp 05/2023)

GS036194 (Exp 06/2023)

GS036760 (Exp 08/2023)

GS036981 (Exp 08/2023)

GS037526 (Exp 08/2023)

GS038177 (Exp 08/2023)

GS038728 (Exp 08/2023)

GS038729 (Exp 09/2023)

GS041108 (Exp 09/2023)

GS039412 (Exp 12/2023)

GS039840 (Exp 12/2023)

GS041109 (Exp 12/2023)

GS041655 (Exp 01/2024)

GS041656 (Exp 05/2024)

NDC:

60429-185-90

Manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.

Product: Enalapril Maleate Tablets, USP (20 mg, 90 tablets)

Variants: 20 mg, 90 tablets

Lot Numbers:

GS035031 (Exp 03/2022)

GS035199 (Exp 03/2022)

GS036495 (Exp 05/2022)

GS036904 (Exp 05/2022)

GS037401 (Exp 09/2022)

GS037986 (Exp 11/2022)

GS038359 (Exp 11/2022)

GS039560 (Exp 11/2022)

GS041110 (Exp 12/2022)

NDC:

60429-186-90

Manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89863

Status: Active

Manufacturer: Golden State Medical Supply Inc.

Sold By: Golden State Medical Supply Inc.

Manufactured In: United States

Units Affected: 4 products (1,471 bottles; 9,058; 31,260 bottles; 1,424 bottles)

Distributed To: Pennsylvania, Massachusetts, Ohio, Texas, Illinois, North Dakota, Hawaii