Quick Facts at a Glance
- Recall Date
- August 8, 2025
- Hazard Level
- HIGH
- Brands
- Glenmark Pharmaceuticals Inc., THEOPHYLLINE
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Glenmark Pharmaceuticals Inc., THEOPHYLLINE
- Product type
- Theophylline extended-release tablets
- Model numbers
- Batch # 19243193, 19243215, 19243231, 19243248, 19243283, 19244530, 19244561, 19250178
- UPC codes
- 68462-356, 68462-380, 68462-380-01, 68462-380-05, 68462-356-01, 68462-356-05
- Sizes
- 100-count bottle
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 8, 2025
Reported by FDA DRUG
August 20, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Glenmark Pharmaceuticals Inc., USA or your healthcare provider for guidance. Notification method: Letter
About This Product
Theophylline extended-release tablets are used to treat certain respiratory conditions by maintaining steady theophylline levels in the body.
Why This Is Dangerous
Dissolution failures may lead to inconsistent drug release, potentially affecting therapeutic effectiveness.
Industry Context
This recall is not identified as part of a broader industry pattern in the provided data.
Real-World Impact
Consumers may experience reduced or inconsistent medication effectiveness, requiring clinician guidance.
Practical Guidance
How to identify if yours is affected
- Verify 100-count bottle packaging
Where to find product info
NDC on the bottle label and packaging; recall page for enforcement details
What timeline to expect
Refund or replacement processing timelines are not specified in the data; contact manufacturer for guidance
If the manufacturer is unresponsive
- File a consumer complaint with the FDA via MedWatch
- Seek guidance from your pharmacist or healthcare provider
- Document all communication and keep packaging for reference
How to prevent similar issues
- Always verify NDC and batch numbers when receiving prescriptions
- Report any loss of efficacy or unusual symptoms to a clinician promptly
- Request replacement product when undergoing recall
Documentation advice
Keep bottle, UPCs, label, batch numbers, and recall notice for records
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Product Details
Brand: Glenmark Pharmaceuticals Inc. USA. Product: Theophylline extended-release tablets 400 mg, Rx only. NDC: 68462-380-01. Form: 100-count bottle. Batch numbers include 19243193, 19243215, 19243231, 19243248, 19243283, 19244530, 19244561, 19250178. Manufactured by Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, India. Distributed nationwide in the USA. Recall date: 2025-08-08. Status: Active. Quantity: 22,656 bottles.
Reported Incidents
No specific injuries or incidents are reported in the provided data.
Key Facts
- Dissolution failure found in UV dissolution tests
- Active recall as of 2025-08-08
- Distributed nationwide in the USA
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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