Severity
Critical
CriticalClass IOngoing
FDA Drug recall · Reported August 7, 2024
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India. Distributed for: BluePoint Laboratories.
Failed Dissolution Specifications
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Amerisource Health Services LLC recalled Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle… - a critical-severity action.
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle… was recalled by Amerisource Health Services LLC in August 7, 2024. Reason: Failed Dissolution Specifications. Check the official notice for the remedy. Verify recall #D-0619-2024 with the FDA Drug before acting.
The recall
Amerisource Health Services LLC issued this critical-severity FDA Drug recall-Failed Dissolution Specifications.
- Critical
- severity level
- Class I
- classification
- August 7, 2024
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0619-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0619-2024) was formally reported on August 7, 2024, with the manufacturer initiating the action on June 25, 2024. It is classified under Critical severity (Class I), with a current status of Ongoing. Amerisource Health Services LLC is listed as the recalling firm, operating out of Columbus, OH. Federal records list the affected scope as 61,231 bottles.
The documented reason for this recall is: Failed Dissolution Specifications Distribution data in the federal record shows the product reached: US Nationwide.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
61,231 bottles
Related Recalls
6
0 from same agency
Product description
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India. Distributed for: BluePoint Laboratories.
Reason for recall
Failed Dissolution Specifications
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | D-0619-2024 |
| Date reported | August 7, 2024 |
| Date initiated | June 25, 2024 |
| Recalling firm | Amerisource Health Services LLC |
| Firm location | Columbus, OH |
| Affected scope | 61,231 bottles |
| Distribution | US Nationwide. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0619-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India. Distributed for: BluePoint Laboratories.. Recalled by Amerisource Health Services LLC. Units affected: 61,231 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 7, 2024. Severity: Critical. Recall number: D-0619-2024.
Where was the recalled product distributed? ▼
Distribution: US Nationwide..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0619-2024) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported August 7, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.