CLASS II ONGOING Drug recall · Reported 4 Nov 2026 · FDA Enforcement Report
Theophylline Extended-Release Tablets, 200 mg recalled
Brandywine Pharmaceuticals is recalling Theophylline Extended-Release Tablets, 200 mg, distributed nationwide in the US. The recall was initiated on 6 Oct 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0111-2027
- FDA event ID
- 100038
- Recalling firm
- Brandywine Pharmaceuticals, West Chester, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Oct 2026
- FDA classified
- 29 Oct 2026
- Reported
- 4 Nov 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
Timeline
| 6 Oct 2026 | Recall initiated by company | |
| 29 Oct 2026 | Classified by FDA | +23 days |
| 4 Nov 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Theophylline Extended-Release Tablets, 200 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-501-10.
Where it was distributed
Nationwide within U.S
Questions about this recall
Why was it recalled?
CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory
Which lots are affected?
Lot: 405620, Expiry: 03/31/2028.
Where was it sold?
Nationwide within U.S
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 10 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 100038This product is part of a recall event; the main page for the event is Theophylline Extended-Release Tablets, 100 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Theophylline Extended-Release Tablets, 100 mg recalled | Brandywine Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Brandywine Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Theophylline Extended-Release Tablets, 100 mg recalled | Brandywine Pharmaceuticals | Potency & Assay | Nationwide |
Other Theophylline recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Theophylline Extended-Release Tablets, 100 mg recalled | Brandywine Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Theophylline extended-release tablets 400mg recalledTheophylline | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Theophylline (Anhydrous) Extended-Release Tablets, 600 mg recalledTheophylline | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Theophylline (Anhydrous) Extended-Release Tablets 400 mg recalledTheophylline | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |