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Recalls Watch

FDA recall 100038: Brandywine Pharmaceuticals, LLC: Theophylline Extended-Release Tablets and 1 more

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FDARecall 100038Medicines

What to do

The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.

Read the official notice on accessdata.fda.gov (opens in a new tab)

Hazard

Why it was recalled

CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory
Text from FDA, unedited.

FDA classification: Class II. Use may cause temporary or medically reversible health consequences, or the chance of serious consequences is remote. Status: Ongoing.

Is it yours? Products and codes

Type the lot, batch, date code, model number or UPC printed on the product. It is compared here, in your browser, with the codes this notice lists. The code is also added to the page address (?lot=…), so a copied link or result carries it.

General information on recalls from the agency: U.S. Food and Drug Administration (opens in a new tab).

  • 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 or code
    Lot: 405617, Expiry: 03/31/2028
    FDA recall number
    D-0110-2027
    Quantity
    1,620 100-count bottles

  • 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 or code
    Lot: 405620, Expiry: 03/31/2028.
    FDA recall number
    D-0111-2027
    Quantity
    1,332 100-count bottles

Distribution (FDA): Nationwide within U.S

About this record

Issued by
U.S. Food and Drug Administration
Firm
Brandywine Pharmaceuticals, LLC
Title
Composed by Recalls Watch from fields of the record; FDA records have no title.

If someone was hurt or swallowed something: call 911, or Poison Help at 1-800-222-1222.

Checking this recall, step by step

Four steps, in this order. Nothing on this page replaces the advice of the agency or of your pharmacist, doctor or dealer.

  1. Read the lot, code or model printed on your package and compare it with the codes in “Is it yours?” below.
  2. Read the instruction under “What to do” and the firm contact above; the official notice is the reference for what to do with that bottle.
  3. Open the official notice to confirm the current text: agencies can update a recall after this page was collected.
  4. Copy, share or print the notice for the pharmacy, the store, the dealer or the family member who owns the product.

Directory and lookup links

Check all notices from this recalling firm in the directory of recalls by brand and manufacturer. Browse more medicines recalls, or check another notice by its number in the recall number lookup.

About this recall

What is the hazard?

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

What should I do if I have this product?

The FDA record of this recall has no instruction for consumers. Compare the lot codes on the notice with your product and follow the notice of the firm. The official report is linked on this page.

How do I know if my product is included?

Compare the lot or code printed on your product with the codes FDA lists on this notice, product by product.

How does the code check on this page work?

You type the lot, batch, date code, model number or UPC from your package and the page compares it, in your browser, with the codes FDA lists on this notice. It reports a match, a possible match (your code is part of a longer listed code) or no match. It only compares text: a notice that describes products by dates, sizes or “all lots” cannot be compared, so “no match” does not clear a product. The comparison runs in your browser and the page does not send the code anywhere, but the code is added to the page address (?lot=…): a link you copy, share or bookmark carries it, and whoever opens that link requests that address from this site.

When was this recall published?

FDA published recall 100038 on November 4, 2026.

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