Nostrum Laboratories Inc recalls Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum
Nostrum Laboratories recalls 400mg Theophylline Extended-Release Tablets due to incorrect lot and expiration date labeling. This may cause medication errors if the wrong batch is used.
Lower-risk recall
CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.
Contact the company & request your remedy
What happened, in plain English
Nostrum Laboratories is recalling 400mg Theophylline Extended-Release Tablets because they were incorrectly labeled with lot and expiration dates. This could lead to using the wrong medication batch, potentially causing treatment errors for patients needing this prescription drug. Read more at govinfonow.com/recall/37343-nostrum-theophylline-tablets-recall-incorrect-lot-exp-date-labels.
Source Summary by GovInfoNow · govinfonow.com/recall/37343-nostrum-theophylline-tablets-recall-incorrect-lot-exp-date-labels · Updated October 5, 2026 · FDA enforcement record: FDA #D-1059-2020
Cite this page
“Nostrum Theophylline Tablets Recall: Incorrect Lot/Exp Date Labels.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37343-nostrum-theophylline-tablets-recall-incorrect-lot-exp-date-labels. Based on FDA recall #D-1059-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1059-2020%22&limit=1).
Why it’s dangerous
The tablets were labeled with incorrect lot and expiration dates. This could lead to using the wrong batch of medication, potentially causing treatment errors for patients who need precise dosing.
Who’s affected
Prescription patients using Theophylline Extended-Release Tablets from Nostrum Laboratories. Those with specific medical conditions requiring precise dosing are most at risk.
How to tell if you have this one
Check for the product name 'Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle' with the lot number THE190501 and expiration date 11/2022.
- Brand
Nostrum- Category
Drug
What to do — step by step
Check Label Details
Verify the lot number and expiration date on the product label. If they match THE190501 and 11/2022, the product is affected.
Questions people ask
Is this product safe to use?
The product is safe to use if the lot and expiration dates match the correct ones. Using the wrong batch could cause medication errors.
How can I confirm if I have the recalled product?
Check for the lot number THE190501 and expiration date 11/2022 on the product label.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact your healthcare provider for guidance on whether to use the product.
Contact Nostrum
We’ve drafted a message you can send Nostrum to request your refund or repair — edit it as you like.
Subject: Recall D-1059-2020 — Nostrum Nostrum Hello, I own a Nostrum that is covered by recall D-1059-2020 from Nostrum. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1059-2020 (March 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1059-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.