Theophylline Extended-Release Tablets recall (Brandywine Pharmaceuticals, LLC)
DrugClass IIOngoing
Summary: Brandywine Pharmaceuticals, LLC is recalling 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.
What is being recalled
Theophylline Extended-Release Tablets, 200 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-501-10.
Why
CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within U.S
How to tell if yours is affected
Lot: 405620, Expiry: 03/31/2028.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0111-2027 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | October 6, 2026 |
| Reported | November 4, 2026 |
| Company | Brandywine Pharmaceuticals, LLC |
| Company location | West Chester, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1,332 100-count bottles |
More recalls from Brandywine Pharmaceuticals, LLC · all drug recalls · recalls from October 2026