Potassium Chloride Extended-Release Capsules Recalled Over Failed Dissolution
Amerisource Health Services LLC is recalling 61,231 bottles of Potassium Chloride Extended-Release Capsules nationwide due to failed dissolution specifications. The medication may not release properly, potentially affecting dosing accuracy.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This FDA Class I recall involves a prescription medication with failed dissolution specifications. Though no illnesses or injuries have been reported in the source material, the Class I classification establishes a minimum severity threshold reflecting potential for serious harm from inconsistent potassium dosing.
Plain-English summary
Amerisource Health Services LLC is recalling Potassium Chloride Extended-Release Capsules, USP (750 mg / 10 mEq K), manufactured by Glenmark Pharmaceuticals Ltd. and distributed by BluePoint Laboratories. A total of 61,231 bottles have been distributed nationwide. The recall is due to failed dissolution specifications, meaning the extended-release capsules may not dissolve and release the medication at the proper rate.
Affected lot numbers include multiple batches for both 100-count and 500-count bottles with expiration dates ranging from July 2024 through September 2025. The failed dissolution could result in inconsistent potassium delivery, affecting the medication's efficacy.
Consumers currently using this product should contact their healthcare provider or pharmacist immediately for guidance. Do not stop taking potassium supplementation without professional medical advice, as potassium balance is essential for proper heart and muscle function. Retailers should remove the affected product from shelves and return it to the manufacturer.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Oral Medication
- Hazard
- dissolution-failure
- dosing-variability
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)
- [100 count bottles]: Lot 17221738
- Exp 07/31/2024
- Lot 17222494
- Exp 10/31/2024
- Lot 17230533
- Exp 01/31/2025
- Lot 17232208
- Exp 09/30/2025
- [500 count bottles]: Lot 17221823
- Lot 17221830
- Lot 17221831
- Exp 08/31/2024
- Lot 17230248
- Lot 17230253
- Lot 17230271
- Exp 12/31/2024
- Lot 17230796
- Lot 17230820
- Exp 02/28/2025
- Lot 17230825
Distribution
Distributed nationwide across the United States.
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