FDA recall, , Moderate risk
Brandywine Pharmaceuticals Theophylline Extended-Release Tablets
Brandywine Pharmaceuticals Theophylline Extended-Release Tablets were recalled for cgmp deviations.
Summary by Recall Canary from the FDA notice
What happened
Brandywine Pharmaceuticals, LLC, of West Chester, Pennsylvania, voluntarily recalled Theophylline Extended-Release Tablets, 100 mg and 200 mg, due to CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory. The tablets were distributed nationwide within the U.S.
The company began the recall on October 6, 2026, and the FDA classified it on October 29, 2026, adding it to the Enforcement Report on October 30, 2026. The recall affects 1,620 100-count bottles of the 100 mg strength and 1,332 100-count bottles of the 200 mg strength.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match your product and all the details in one listed combination.
An NDC (National Drug Code) is usually printed on the drug's label.
Theophylline Extended-Release Tablets
- Strength
- 100 mg
- NDC
- 71321-500-10
- Lot code
- 405617
- Strength
- 200 mg
- NDC
- 71321-501-10
- Lot code
- 405620
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
Nationwide within U.S
- Recalled by
- Brandywine Pharmaceuticals, LLCWest Chester, Pennsylvania
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100038
- Recall numbers
- D-0110-2027 to D-0111-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
All recalls from Brandywine Pharmaceuticals, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Brandywine Pharmaceuticals, LLC began the recall
FDA rated the recall Class II (moderate risk)
FDA posted the recall to its Enforcement Report
Added to Recall Canary
