Reported Nov 4, 2026 · Ongoing
Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals,…
Brandywine Pharmaceuticals, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Brandywine Pharmaceuticals, LLC · 600 W Strasburg Rd · West Chester, PA · 19382-1955
Is this the product you have?
- Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle
- Distributed byBrandywine Pharmaceuticals, LLC, West Chester, PA 19382
- NDC71321-500-10
- Lot codes and dates
- Lot405617
- Expiry03/31/2028
- Amount recalled
- 1,620 100-count bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory
This product could cause temporary or reversible health problems — stop using it.
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