Brandywine Pharmaceuticals, LLC recalls Theophylline Extended-Release Tablets
- Recalling company
- Brandywine Pharmaceuticals, LLC
- Product
- Theophylline Extended-Release Tablets, 200 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-501-10.
- Reason
- CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 6, 2026
- Reported
- Nov 4, 2026
- Distribution
- Nationwide within U.S
- Status
- Ongoing
- Quantity
- 1,332 100-count bottles
- Lot / codes
- Lot: 405620, Expiry: 03/31/2028.
- Company location
- West Chester, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0111-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0111-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.