Potassium Chloride Extended-Release Capsules Recalled Nationwide for Failed Dissolution Specifications
Glenmark Pharmaceuticals is recalling Potassium Chloride Extended-Release Capsules (750 mg) nationwide due to failed dissolution specifications that may affect medication delivery. Approximately 36,630 bottles are affected.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which mandates a minimum severity score of 4 (Severe) per the rubric. No deaths or serious injuries have been reported, preventing a higher Critical rating.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Potassium Chloride Extended-Release Capsules, USP (750 mg, 10 mEq K) distributed nationwide. The recall affects approximately 36,630 bottles supplied in 500-count bottles with NDC 68462-357-05. The product is manufactured by Glenmark Pharmaceuticals Ltd. in Pithampur, Madhya Pradesh, India.
The recall was initiated due to the product failing dissolution specifications. Extended-release capsules are designed to dissolve and release medication gradually; failure to meet dissolution specifications means the medication may not be delivered properly to the body.
Multiple lot numbers are affected, with expiration dates ranging from May 2024 through November 2024. Affected lots include 17221197, 17221386, 17221385 (Exp May-31-24); 17221489, 17221504, 17221530 (Exp Jun-30-24); 17221561, 17221579, 17221568, 17221702, 17221704 (Exp Jul-31-24); 17221898, 17221993, 17222029 (Exp Aug-31-24); 17222300, 17222304, 17222278, 17222609, 17222395 (Exp Oct-31-24); and 17222589, 17222605, 17222613 (Exp Nov-30-24).
Patients and healthcare providers should check if their medication matches the recalled lot numbers. If affected product is identified, consult with a healthcare provider for guidance on whether to continue using this medication and what alternatives may be available.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- Affected units
- 36,630
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)
- Lot #: 17221197
- 17221386
- 17221385
- Exp May-31-24
- 17221489
- 17221504
- 17221530
- Exp Jun-30-24
- 17221561
- 17221579
- 17221568
- 17221702
- 17221704
- Exp Jul-31-24
- 17221898
- 17221993
- 17222029
- Exp Aug-31-24
- 17222300
- 17222304
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Glenmark Pharmaceuticals Inc., USA 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 →Related recalls
Same brand · POTASSIUM CHLORIDE
- CriticalPotassium chloride bags recalled because the overwrap understates the declared strength
FDA (Drugs) · 2025-11-26
- CriticalConcentrated potassium chloride recalled over an understated strength on the overwrap
FDA (Drugs) · 2025-11-26
- SeverePotassium Chloride Injection Strength Mislabeled on Packaging Overwrap
FDA (Drugs) · 2025-03-19
- SeverePotassium Chloride Injection Recalled: Overwrap Labeling Shows Incorrect Strength
FDA (Drugs) · 2025-03-19
- HighPotassium Chloride Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2025-02-12
Same manufacturer · Glenmark Pharmaceuticals Inc., USA
See all →- ModerateAzelaic Acid Gel 15% Recalled Over Grainy, Gritty, or Sandy Texture
FDA (Drugs) · 2026-08-05
- ModerateAlyacen 7/7/7 birth control tablets failed total impurities specification
FDA (Drugs) · 2026-06-24
- ModerateOndansetron tablets recalled because blister packs are not fully sealed
FDA (Drugs) · 2026-01-07
- CriticalFrozen chopped methi recalled after testing positive for Salmonella
FDA (Drugs) · 2025-12-17
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over traces of another drug
FDA (Drugs) · 2025-12-10
Same hazard · dissolution failure
See all →- ModerateApotex Recalls Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateAjanta Pharma Recalls Ranolazine Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateMylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures
FDA (Drugs) · 2026-09-09
- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
Similar recalls
- SeverePotassium Chloride Extended-Release Capsules Recalled Over Failed Dissolution
FDA (Drugs) · 2024-08-07
- HighPotassium Chloride Extended Release Capsules Recalled for Dissolution Defect
FDA (Drugs) · 2024-07-24
- HighPotassium Chloride Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2025-02-12
- ModeratePotassium Chloride Extended-Release Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2021-10-20
- ModerateStrides Recalls Potassium Chloride Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2020-10-07
- ModerateIndomethacin Extended-Release Capsules Recalled Due to Failed Dissolution Specifications
FDA (Drugs) · 2024-09-04