Unrated Drug recall · FDA · Published November 17, 2020

BASF recalls Kollidon CL-M Crospovidone due to theophylline contamination

BASF recalls Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized in 30kg plastic drums due to cross contamination with theophylline. This may pose health risks if used in medications.

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

🇺🇸 FDA recall #D-0149-2021Drug BASF ›

Recall notice

Cross contamination: the excipient was found to be contaminated with theophylline.

Take action

Contact the company

Recalling firmBASF Corporation100 Park Ave · Florham Park, NJ 07932-1049

✎ GovInfoNow plain-language explainer

BASF has recalled Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized products in 30kg plastic drums because they were contaminated with theophylline. This contamination could lead to health risks if the product is used in medications. Read more at govinfonow.com/recall/36676-basf-recalls-kollidon-cl-m-crospovidone-due-to-theophylline-contamination.

Source Summary by GovInfoNow · govinfonow.com/recall/36676-basf-recalls-kollidon-cl-m-crospovidone-due-to-theophylline-contamination · Updated October 4, 2026 · FDA enforcement record: FDA #D-0149-2021

Cite this page

“BASF recalls Kollidon CL-M Crospovidone due to theophylline contamination.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36676-basf-recalls-kollidon-cl-m-crospovidone-due-to-theophylline-contamination. Based on FDA recall #D-0149-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0149-2021%22&limit=1).

The FDA announced on November 17, 2020, that BASF Corporation voluntarily recalled Kollidon CL-M Crospovidone due to cross-contamination with theophylline. The drug excipient was found to be contaminated during manufacturing.

How to tell if you have it

Brand: BASF
Product: Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized
Packaging: 30 kg plastic drums
Manufacturer: BASF SE
Co-Manufacturer: Siegfried PharmaChemikalien Minden GmbH
Lot codes: Batch # 18472036, 18472041
Quantity: 4560 kg
Distribution: USA Nationwide and Worldwide

The hazard

The recall was initiated because the excipient was found to be contaminated with theophylline. This cross-contamination poses a risk to products containing this ingredient.

Context

GovInfoNow's records show other recent recalls of similar products include Taro Recalls Children's Ibuprofen Due to Foreign Substance (2026-03-02), Trifluent Pharma Wound Care Gel Recall: Contaminated Product from Shared Facility (2026-04-08), and Zep Alcohol Sanitizer Spray Recall: Microbial Contamination Risk (2026-05-22).

How to tell if you have this one

Check for Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized products in 30kg plastic drums. The batch numbers 18472036 and 18472041 are associated with this recall.

Brand
BASF
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify if your product matches the description: Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized in 30kg plastic drums with batch numbers 18472036 or 18472041.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “USA Nationwide and Worldwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 36 days after the firm started it.

Nov 17, 2020Firm started the recall
Dec 15, 2020FDA classified it Class II
Dec 23, 2020Published in FDA’s Enforcement Report

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/36676-basf-recalls-kollidon-cl-m-crospovidone-due-to-theophylline-contamination">BASF recalls Kollidon CL-M Crospovidone due to theophylline contamination (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-0149-2021 (November 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0149-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 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.