Unrated Drug recall · FDA · Published October 6, 2026

Brandywine Theophylline Recall: Stability Testing Deviation

Brandywine Pharmaceuticals recalls 1,620 bottles of Theophylline 100mg due to CGMP deviations in stability testing. Check your lot number.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0110-2027Drug Brandywine Pharmaceuticals ›

Recall notice

CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory

✎ GovInfoNow plain-language explainer

Brandywine Pharmaceuticals is recalling one lot of Theophylline Extended-Release Tablets (100 mg) because of current Good Manufacturing Practice (CGMP) deviations. Specifically, there was an interruption in the ongoing stability testing program conducted at a third-party laboratory. The recall affects 1,620 bottles distributed nationwide. Read more at govinfonow.com/recall/2084757-brandywine-pharmaceuticals-llc-recalls-theophylline-extended-release-tablets-100-mg.

Source Summary by GovInfoNow · govinfonow.com/recall/2084757-brandywine-pharmaceuticals-llc-recalls-theophylline-extended-release-tablets-100-mg · Published November 10, 2026 · Updated November 11, 2026 · FDA enforcement record: FDA #D-0110-2027

Cite this page

“Brandywine Theophylline Recall: Stability Testing Deviation.” GovInfoNow, updated November 11, 2026. https://govinfonow.com/recall/2084757-brandywine-pharmaceuticals-llc-recalls-theophylline-extended-release-tablets-100-mg. Based on FDA recall #D-0110-2027 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0110-2027%22&limit=1).

Brandywine Pharmaceuticals, LLC voluntarily recalled Theophylline Extended-Release Tablets, 100 mg, due to current Good Manufacturing Practice deviations involving an interruption in stability testing, the FDA said on Oct. 6, 2026.

How to tell if you have it

Brand: Brandywine Pharmaceuticals
Product: Theophylline Extended-Release Tablets, 100 mg
NDC: 71321-500-10
Lot: 405617
Expiry: 03/31/2028
Quantity: 1,620 100-count bottles

The hazard

The recall stems from CGMP deviations specifically an interruption in the ongoing stability testing program conducted at a third-party laboratory.

Context

GovInfoNow's records show other recent recalls of similar products include Blaine Labs TERPENICOL Antifungal Solution Recall (2026-04-08) and Wells Pharma Fentanyl Citrate Injectable Solution Recall (2026-04-01).

How to tell if you have this one

Check your medication bottle for NDC 71321-500-10 and Lot number 405617. The tablets are in 100-count bottles distributed by Brandywine Pharmaceuticals, LLC of West Chester, PA, with an expiry date of 03/31/2028.

Brand
Brandywine Pharmaceuticals
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide within U.S

Recall number	Product, codes & lots	Quantity
D-0110-2027	Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-500-10; Lot: 405617, Expiry: 03/31/2028	1,620 100-count bottles
D-0111-2027	Theophylline Extended-Release Tablets, 200 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-501-10.; Lot: 405620, Expiry: 03/31/2028.	1,332 100-count bottles

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within U.S” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 29 days after the firm started it.

Oct 6, 2026Firm started the recall
Oct 29, 2026FDA classified it Class II
Nov 4, 2026Published in FDA’s Enforcement Report
Nov 10, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/2084757-brandywine-pharmaceuticals-llc-recalls-theophylline-extended-release-tablets-100-mg">Brandywine Theophylline Recall: Stability Testing Deviation (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0110-2027 (October 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0110-2027 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on November 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.