FDA Drugs recall ·
Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle… recall
- Recall number
- D-0110-2027
- Date
- (initiated October 6, 2026)
- Company / brand
- Brandywine Pharmaceuticals, LLC
600 W Strasburg Rd, West Chester, PA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,620 100-count bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: 405617, Expiry: 03/31/2028
Distribution
Nationwide within U.S
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0110-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.