Earlier this week, the FDA announced a recall of extended-release Potassium Chloride capsules due to a failure to dissolve as intended. When functioning properly, the drug is slowly released into the patient’s system, allowing for proper processing. However, failure of the dissolution process may lead to sudden release of the entirety of the capsule, causing severe and dangerous health outcomes.
Now, the FDA has added 21 additional lots to the recall list for this medication. These lots were manufactured and distributed by Blue Point Laboratories.
As of the writing of this notice, the FDA has not announced any adverse events related to the contamination.
SUMMARY
Date of Recall:
Announced: June 25, 2024
Public Notification: June 26, 2024
Name(s) of Drug:
Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEq K
Company Name:
American Health Packaging
Blue Point Laboratories
Drug Indication:
Potassium Supplementation
Product Description
Potassium Chloride Extended-Release Capsules are available by prescription only. Pharmacies nationwide distributed the capsules to the facility and consumer levels. Each was packaged in either 100-count or 500-count bottles and labeled clearly with a teal, blue, and white label. The NDC number, expiration date, batch number, and product name are clearly printed on the package.
Reason for Recall
American Health Packaging is voluntarily initiating the recall. They have not publicly stated how the failed dissolution was discovered, but the FDA report states that no serious adverse events have been reported as a result of the failure.
Impacts
Consumers who continue to use the faulty drug may experience serious health outcomes related to a sudden increase in their potassium levels. High potassium levels may lead to effects such as:
- Irregular heartbeat
- Cardiac arrest (heart attack)
- Severe muscle weakness
- Death
Recall Lot Information
All medical facilities and distributors who stock Potassium Chloride Capsules and consumers who take the capsules must carefully examine their inventory to determine if their product is included in the recall. Compare each bottle’s NDC, lot numbers, strength, and expiration date to the chart below. If any are found to match, read further for instructions on participating in the recall.
| Sr. No | NDC | Product Name | Batch No. | Expiry Date |
| 1. | 68001-396-00 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 100 count | 17221738 | 07/31/2024 |
| 2. | 68001-396-00 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 100 count | 17222494 | 10/31/2024 |
| 3. | 68001-396-00 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 100 count | 17230533 | 01/31/2025 |
| 4. | 68001-396-00 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 100 count | 17232208 | 09/30/2025 |
| 5. | 68001-396-03 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 500 count | 17221823 | 07/31/2024 |
| 6. | 68001-396-03 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 500 count | 17221830 | 07/31/2024 |
| 7. | 68001-396-03 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 500 count | 17221831 | 08/31/2024 |
| 8. | 68001-396-03 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 500 count | 17230248 | 12/31/2024 |
| 9. | 68001-396-03 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 500 count | 17230253 | 12/31/2024 |
| 10. | 68001-396-03 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 500 count | 17230271 | 12/31/2024 |
| 11. | 68001-396-03 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 500 count | 17230796 | 02/28/2025 |
| 12. | 68001-396-03 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 500 count | 17230820 | 02/28/2025 |
| 13. | 68001-396-03 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 500 count | 17230825 | 03/31/2025 |
| 14. | 68001-396-03 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 500 count | 17230833 | 03/31/2025 |
| 15. | 68001-396-03 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 500 count | 17230840 | 03/31/2025 |
| 16. | 68001-396-03 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 500 count | 17231537 | 06/30/2025 |
| 17. | 68001-396-03 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 50 count | 17231540 | 06/30/2025 |
| 18. | 68001-396-03 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 500 count | 17231719 | 06/30/2025 |
| 19. | 68001-396-03 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 500 count | 17231737 | 06/30/2025 |
| 20. | 68001-396-03 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 500 count | 17232111 | 09/30/2025 |
| 21. | 68001-396-03 | Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K – 50 count | 17232164 | 09/30/2025 |
Have you found that your medication is part of the recall? Here’s what you should do:
Consumer Recall Instructions
If you find that your lot of medication is part of this recall, do the following:
- Do not take the recalled medication.
- Ask your doctor to replace the recalled drug with a new bottle. If the lot number, NDC number, and expiration date do not match the chart, the medication is not included in this recall.
- If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
Healthcare System Recall Instructions
- Examine all inventory and remove stock affected by the recall immediately.
- If you have questions, contact Sedgwick at 1-855-695-8564. They are available from 8 a.m. to 5 p.m. EST, Monday through Friday.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Wholesaler/Retailer Recall Instructions
- Examine all inventory and remove stock affected by the recall immediately.
- If you have questions, contact Sedgwick at 1-855-695-8564. They are available from 8 a.m. to 5 p.m. EST, Monday through Friday. Notify them of recalled batches that have already been shipped to medical facilities or distributed to consumers.
- Notify affected medical facilities and consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
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Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!
