Medications & Supplements/Prescription Drugs

Glenmark Potassium Chloride Extended-Release Capsules Recalled for Dissolution Failure

Agency Publication Date: July 17, 2024

Summary

Glenmark Pharmaceuticals Inc., USA is recalling approximately 322,470 bottles of Potassium Chloride Extended-Release Capsules, USP, 750 mg (10 mEq K). The recall includes both 100-count and 500-count bottles. This recall was initiated due to the product failing dissolution specifications and manufacturing quality (CGMP) deviations discovered during testing.

Risk

Failed dissolution specifications mean the medication may not release properly in the body. This could result in the medication being ineffective for treating low potassium levels or, conversely, a sudden release of the drug that could lead to an overdose.

What You Should Do

This recall affects Glenmark Potassium Chloride Extended-Release Capsules, USP, 750 mg (10 mEq K) sold in 100-count bottles (NDC 68462-357-01) and 500-count bottles (NDC 68462-357-05).
To identify if your medication is affected, check the NDC number, lot number, and expiration date printed on the bottle label.
Due to the high number of affected batches, 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 Glenmark Pharmaceuticals Inc., USA for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional information.

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: Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K (100-count)

Variants: 750 mg, 10 mEq K, 100-count bottle

UPC Codes:

368462357019

Lot Numbers (65):

17221446 (Exp May-31-24)

17221445 (Exp May-31-24)

17221393 (Exp Jun-30-24)

17221403 (Exp Jun-30-24)

17221405 (Exp Jun-30-24)

17221503 (Exp Jun-30-24)

17221508 (Exp Jun-30-24)

17221567 (Exp Jul-31-24)

17221566 (Exp Jul-31-24)

17221719 (Exp Jul-31-24)

17221731 (Exp Jul-31-24)

17221891 (Exp Aug-31-24)

17221892 (Exp Aug-31-24)

17221900 (Exp Aug-31-24)

17221992 (Exp Aug-31-24)

17222022 (Exp Aug-31-24)

17222056 (Exp Sep-30-24)

17222043 (Exp Sep-30-24)

17222068 (Exp Sep-30-24)

17222079 (Exp Sep-30-24)

17222099 (Exp Sep-30-24)

17222103 (Exp Sep-30-24)

17222114 (Exp Sep-30-24)

17222119 (Exp Sep-30-24)

17222188 (Exp Sep-30-24)

17222199 (Exp Sep-30-24)

17222209 (Exp Sep-30-24)

17222200 (Exp Sep-30-24)

17222265 (Exp Oct-31-24)

17222269 (Exp Oct-31-24)

17222527 (Exp Nov-30-24)

17222530 (Exp Nov-30-24)

17222583 (Exp Nov-30-24)

17222586 (Exp Nov-30-24)

17230051 (Exp Nov-30-24)

17230075 (Exp Nov-30-24)

17230067 (Exp Nov-30-24)

17230074 (Exp Dec-31-24)

17230221 (Exp Dec-31-24)

17230468 (Exp Jan-31-25)

17230479 (Exp Jan-31-25)

17230553 (Exp Jan-31-25)

17230543 (Exp Jan-31-25)

17230561 (Exp Jan-31-25)

17230619 (Exp Feb-28-25)

17230624 (Exp Feb-28-25)

17230879 (Exp Mar-31-25)

17230890 (Exp Mar-31-25)

17230918 (Exp Mar-31-25)

17230984 (Exp Mar-31-25)

NDC:

68462-357-01

Product: Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K (500-count)

Variants: 750 mg, 10 mEq K, 500-count bottle

UPC Codes:

368462357057

Lot Numbers (54):

17221197 (Exp May-31-24)

17221386 (Exp May-31-24)

17221385 (Exp May-31-24)

17221489 (Exp Jun-30-24)

17221504 (Exp Jun-30-24)

17221530 (Exp Jun-30-24)

17221561 (Exp Jul-31-24)

17221579 (Exp Jul-31-24)

17221568 (Exp Jul-31-24)

17221702 (Exp Jul-31-24)

17221704 (Exp Jul-31-24)

17221898 (Exp Aug-31-24)

17221993 (Exp Aug-31-24)

17222029 (Exp Aug-31-24)

17222300 (Exp Oct-31-24)

17222304 (Exp Oct-31-24)

17222278 (Exp Oct-31-24)

17222609 (Exp Oct-31-24)

17222395 (Exp Oct-31-24)

17222589 (Exp Nov-30-24)

17222605 (Exp Nov-30-24)

17222613 (Exp Nov-30-24)

17230186 (Exp Dec-31-24)

17230192 (Exp Dec-31-24)

17230213 (Exp Dec-31-24)

17230278 (Exp Dec-31-24)

17230399 (Exp Dec-31-24)

17230406 (Exp Jan-31-25)

17230412 (Exp Jan-31-25)

17230427 (Exp Jan-31-25)

17230444 (Exp Jan-31-25)

17230453 (Exp Jan-31-25)

17230495 (Exp Jan-31-25)

17230574 (Exp Feb-28-25)

17230585 (Exp Feb-28-25)

17230608 (Exp Feb-28-25)

17230629 (Exp Feb-28-25)

17230883 (Exp Mar-31-25)

17230921 (Exp Mar-31-25)

17231087 (Exp Apr-30-25)

17231339 (Exp Apr-30-25)

17231360 (Exp May-31-25)

17231711 (Exp Jun-30-25)

17231745 (Exp Jun-30-25)

17231819 (Exp Jul-31-25)

17231820 (Exp Jul-31-25)

17231936 (Exp Jul-31-25)

17231957 (Exp Jul-31-25)

17231998 (Exp Aug-31-25)

17232012 (Exp Aug-31-25)

NDC:

68462-357-05

Product Images

Label, Glenmark Potassium Chloride Extended Release 750mg Capsules, 100 count

Label, Glenmark Potassium Chloride Extended Release 750mg Capsules, 500 count

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94715

Status: Active

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: Retail Pharmacies

Manufactured In: India

Units Affected: 2 products (285,840 bottles; 36,630 bottles)

Distributed To: Nationwide

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 · FDA Press Release · 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 Glenmark Potassium Chloride Extended-Release Capsules, USP, 750 mg (10 mEq K) sold in 100-count bottles (NDC 68462-357-01) and 500-count bottles (NDC 68462-357-05).

To identify if your medication is affected, check the NDC number, lot number, and expiration date printed on the bottle label.

Due to the high number of affected batches, 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 Glenmark Pharmaceuticals Inc., USA for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional information.

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: Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K (100-count)

Variants: 750 mg, 10 mEq K, 100-count bottle

UPC Codes:

368462357019

Lot Numbers (65):

17221446 (Exp May-31-24)

17221445 (Exp May-31-24)

17221393 (Exp Jun-30-24)

17221403 (Exp Jun-30-24)

17221405 (Exp Jun-30-24)

17221503 (Exp Jun-30-24)

17221508 (Exp Jun-30-24)

17221567 (Exp Jul-31-24)

17221566 (Exp Jul-31-24)

17221719 (Exp Jul-31-24)

17221731 (Exp Jul-31-24)

17221891 (Exp Aug-31-24)

17221892 (Exp Aug-31-24)

17221900 (Exp Aug-31-24)

17221992 (Exp Aug-31-24)

17222022 (Exp Aug-31-24)

17222056 (Exp Sep-30-24)

17222043 (Exp Sep-30-24)

17222068 (Exp Sep-30-24)

17222079 (Exp Sep-30-24)

17222099 (Exp Sep-30-24)

17222103 (Exp Sep-30-24)

17222114 (Exp Sep-30-24)

17222119 (Exp Sep-30-24)

17222188 (Exp Sep-30-24)

17222199 (Exp Sep-30-24)

17222209 (Exp Sep-30-24)

17222200 (Exp Sep-30-24)

17222265 (Exp Oct-31-24)

17222269 (Exp Oct-31-24)

17222527 (Exp Nov-30-24)

17222530 (Exp Nov-30-24)

17222583 (Exp Nov-30-24)

17222586 (Exp Nov-30-24)

17230051 (Exp Nov-30-24)

17230075 (Exp Nov-30-24)

17230067 (Exp Nov-30-24)

17230074 (Exp Dec-31-24)

17230221 (Exp Dec-31-24)

17230468 (Exp Jan-31-25)

17230479 (Exp Jan-31-25)

17230553 (Exp Jan-31-25)

17230543 (Exp Jan-31-25)

17230561 (Exp Jan-31-25)

17230619 (Exp Feb-28-25)

17230624 (Exp Feb-28-25)

17230879 (Exp Mar-31-25)

17230890 (Exp Mar-31-25)

17230918 (Exp Mar-31-25)

17230984 (Exp Mar-31-25)

NDC:

68462-357-01

Product: Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K (500-count)

Variants: 750 mg, 10 mEq K, 500-count bottle

UPC Codes:

368462357057

Lot Numbers (54):

17221197 (Exp May-31-24)

17221386 (Exp May-31-24)

17221385 (Exp May-31-24)

17221489 (Exp Jun-30-24)

17221504 (Exp Jun-30-24)

17221530 (Exp Jun-30-24)

17221561 (Exp Jul-31-24)

17221579 (Exp Jul-31-24)

17221568 (Exp Jul-31-24)

17221702 (Exp Jul-31-24)

17221704 (Exp Jul-31-24)

17221898 (Exp Aug-31-24)

17221993 (Exp Aug-31-24)

17222029 (Exp Aug-31-24)

17222300 (Exp Oct-31-24)

17222304 (Exp Oct-31-24)

17222278 (Exp Oct-31-24)

17222609 (Exp Oct-31-24)

17222395 (Exp Oct-31-24)

17222589 (Exp Nov-30-24)

17222605 (Exp Nov-30-24)

17222613 (Exp Nov-30-24)

17230186 (Exp Dec-31-24)

17230192 (Exp Dec-31-24)

17230213 (Exp Dec-31-24)

17230278 (Exp Dec-31-24)

17230399 (Exp Dec-31-24)

17230406 (Exp Jan-31-25)

17230412 (Exp Jan-31-25)

17230427 (Exp Jan-31-25)

17230444 (Exp Jan-31-25)

17230453 (Exp Jan-31-25)

17230495 (Exp Jan-31-25)

17230574 (Exp Feb-28-25)

17230585 (Exp Feb-28-25)

17230608 (Exp Feb-28-25)

17230629 (Exp Feb-28-25)

17230883 (Exp Mar-31-25)

17230921 (Exp Mar-31-25)

17231087 (Exp Apr-30-25)

17231339 (Exp Apr-30-25)

17231360 (Exp May-31-25)

17231711 (Exp Jun-30-25)

17231745 (Exp Jun-30-25)

17231819 (Exp Jul-31-25)

17231820 (Exp Jul-31-25)

17231936 (Exp Jul-31-25)

17231957 (Exp Jul-31-25)

17231998 (Exp Aug-31-25)

17232012 (Exp Aug-31-25)

NDC:

68462-357-05