Theophylline Extended-Release Tablets 100 mg Recall: CGMP Deviations
Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-500-10
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Theophylline Extended-Release Tablets 100 mg recalled?
CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-500-10
Which lot codes, UPCs or models are affected?
Lot: 405617, Expiry: 03/31/2028
- Agency record number
- D-0110-2027
- Product
- Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-500-10
- Recalling firm
- Brandywine Pharmaceuticals, LLC
- Quantity
- 1,620 100-count bottles
- Distribution
- Nationwide within U.S
- Recall started
- October 6, 2026
- Report date
- November 4, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)