Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported July 24, 2024
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,
Failed Dissolution Specifications: results below specifications
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Glenmark Pharmaceuticals Inc., USA recalled Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b… - a moderate-severity action.
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b… was recalled by Glenmark Pharmaceuticals Inc., USA in July 24, 2024. Reason: Failed Dissolution Specifications: results below specifications. Check the official notice for the remedy. Verify recall #D-0612-2024 with the FDA Drug before acting.
The recall
Glenmark Pharmaceuticals Inc., USA issued this moderate-severity FDA Drug recall-Failed Dissolution Specifications: results below specifications.
- Moderate
- severity level
- Class II
- classification
- July 24, 2024
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0612-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0612-2024) was formally reported on July 24, 2024, with the manufacturer initiating the action on June 28, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Glenmark Pharmaceuticals Inc., USA is listed as the recalling firm, operating out of Mahwah, NJ. Federal records list the affected scope as a) 145,800 bottles; b) 1,368 bottles.
The documented reason for this recall is: Failed Dissolution Specifications: results below specifications Distribution data in the federal record shows the product reached: USA 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
a) 145,800 bottles; b) 1,368 bottles
Related Recalls
6
0 from same agency
Product description
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,
Reason for recall
Failed Dissolution Specifications: results below specifications
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0612-2024 |
| Date reported | July 24, 2024 |
| Date initiated | June 28, 2024 |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA |
| Firm location | Mahwah, NJ |
| Affected scope | a) 145,800 bottles; b) 1,368 bottles |
| Distribution | USA 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-0612-2024) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: a) 145,800 bottles; b) 1,368 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: results below specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 24, 2024. Severity: Moderate. Recall number: D-0612-2024.
Where was the recalled product distributed? ▼
Distribution: USA Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0612-2024) 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 July 24, 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.