Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported August 20, 2025
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability int…
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Glenmark Pharmaceuticals Inc., USA recalled Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: … - a moderate-severity action.
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: … was recalled by Glenmark Pharmaceuticals Inc., USA in August 20, 2025. Reason: Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for…. Check the official notice for the remedy. Verify recall #D-0583-2025 with the FDA Drug before acting.
The recall
Glenmark Pharmaceuticals Inc., USA issued this moderate-severity FDA Drug recall-Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for….
- Moderate
- severity level
- Class II
- classification
- August 20, 2025
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0583-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0583-2025) was formally reported on August 20, 2025, with the manufacturer initiating the action on August 8, 2025. 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 22,656 bottles.
The documented reason for this recall is: Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results d… 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
22,656 bottles
Related Recalls
6
0 from same agency
Product description
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01
Reason for recall
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0583-2025 |
| Date reported | August 20, 2025 |
| Date initiated | August 8, 2025 |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA |
| Firm location | Mahwah, NJ |
| Affected scope | 22,656 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-0583-2025) 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? ▼
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 22,656 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 20, 2025. Severity: Moderate. Recall number: D-0583-2025.
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-0583-2025) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with AMASKY Nursing Pillows Recalled Due to Risk of Serious Inju… →
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 20, 2025. 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.