Prescription Potassium Chloride Extended-Release Capsules Recalled for Manufacturing Deviations
Glenmark Pharmaceuticals is recalling Potassium Chloride Extended-Release Capsules nationwide due to manufacturing practice deviations. The voluntary recall affects multiple lot numbers, with no reported illnesses or injuries.
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 with no reported illnesses or injuries. The hazard is a CGMP deviation—a manufacturing quality issue without reported specific harm. Per the rubric, voluntary precautionary recalls with no reported illness and theoretical hazards are classified as Moderate.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA, is recalling Potassium Chloride Extended-Release Capsules, USP, in 500-count bottles containing 750 mg (10 mEq K). The recall affects multiple lot numbers distributed nationwide, with expiration dates ranging from December 2024 through September 2025.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations discovered during manufacturing. No illnesses or injuries related to this product have been reported as of the recall notice date.
The product is a prescription medication (NDC 68462-357-05) manufactured by Glenmark Pharmaceuticals Ltd. in Pithampur, Madhya Pradesh, India, and manufactured for Glenmark Pharmaceuticals Inc. in Mahwah, New Jersey. This is a voluntary recall initiated by the firm, with the recall ongoing as of the report date of July 24, 2024.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Drug
- Hazard
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 #: 17230186
- 17230192
- 17230213
- 17230278
- 17230399
- Exp Dec-31-24
- 17230406
- 17230412
- 17230427
- 17230444
- 17230453
- 17230495
- Exp Jan-31-25
- 17230574
- 17230585
- 17230608
- 17230629
- Exp Feb-28-25
- 17230883
- 17230921
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
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