Enalapril Maleate
FDA Recall NDC 60429-185
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 4 recorded enforcement report(s) associated with Enalapril Maleate (NDC 60429-185). A significant event, classified as Class II, was initiated on Mar 16, 2022 by Golden State Medical Supply, Inc.. The reported reason for this action was: "CGMP Deviations"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations
Mar 16, 2022
Jul 13, 2022
31,260 bottles
Recall Profile & Regulatory Data
Event ID
89863
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
Product Description
Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
Batch or Lot Expiration Information
Lot# 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; Lots: GS034810, Exp.: 01/2023; Lots: GS035240, GS035598, Exp.: 05/2023; Lots: GS036194, Exp.: 06/2023; Lots: GS036760, GS036981,GS037526, GS038177, GS038728, Exp.: 08/2023; Lots: GS038729, GS041108, Exp.: 09/2023; Lots: GS039412, GS039840, GS041109, Exp.: 12/2023; Lot: GS041655, Exp.: 01/2024; Lot: GS041656, Exp.: 05/2024. (NDC: 60429-185-90).
Affected Packages Involved in this Recall
60429-183-30Product
60429-183-10Product
60429-183-90Product
60429-184-30Product
60429-184-10Product
60429-184-90Product
60429-185-30Product
60429-185-10Product
60429-185-90Product
60429-186-30Product
60429-186-10Product
60429-186-90Product
Class II Ongoing
CGMP Deviations
Mar 16, 2022
Jul 13, 2022
9,058
Recall Profile & Regulatory Data
Event ID
89863
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
Product Description
Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
Batch or Lot Expiration Information
Lot# 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; Lots: GS038089, GS038763, GS039559, GS040150, Exp.: 10/2023; Lots: GS040151, GS040708, GS041107, Exp.: 12/2023; Lot: GS041654, Exp.: 03/2024.
Affected Packages Involved in this Recall
60429-183-30Product
60429-183-10Product
60429-183-90Product
60429-184-30Product
60429-184-10Product
60429-184-90Product
60429-185-30Product
60429-185-10Product
60429-185-90Product
60429-186-30Product
60429-186-10Product
60429-186-90Product
Class II Ongoing
CGMP Deviations
Mar 16, 2022
Jul 13, 2022
1,424 bottles
Recall Profile & Regulatory Data
Event ID
89863
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
Product Description
Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
Batch or Lot Expiration Information
Lot# 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).
Affected Packages Involved in this Recall
60429-183-30Product
60429-183-10Product
60429-183-90Product
60429-184-30Product
60429-184-10Product
60429-184-90Product
60429-185-30Product
60429-185-10Product
60429-185-90Product
60429-186-30Product
60429-186-10Product
60429-186-90Product
Class II Ongoing
CGMP Deviations
Mar 16, 2022
Jul 13, 2022
1,471 bottles
Recall Profile & Regulatory Data
Event ID
89863
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
Product Description
Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA, USA.
Batch or Lot Expiration Information
Lot# 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, GS040149, Exp.: 11/2023. (NDC: 60429-183-90).
Affected Packages Involved in this Recall
60429-183-30Product
60429-183-10Product
60429-183-90Product
60429-184-30Product
60429-184-10Product
60429-184-90Product
60429-185-30Product
60429-185-10Product
60429-185-90Product
60429-186-30Product
60429-186-10Product
60429-186-90Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
