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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

BASF Corporation: Kollidon CL-M Crospovidone Excipient Recalled for Theophylline Contamination

Agency Publication Date: December 15, 2020
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Summary

BASF Corporation is recalling 4,560 kilograms of Kollidon CL-M Crospovidone, a micronized inactive ingredient (excipient) used in manufacturing pharmaceutical products. This recall was initiated because the ingredient was found to be cross-contaminated with theophylline, a medication used to treat respiratory diseases. The affected batches were packaged in 30 kg plastic drums and distributed to pharmaceutical manufacturers nationwide and worldwide between November 2020 and present. Consumers should contact their healthcare provider if they suspect their medication was made using these contaminated materials.

Risk

The cross-contamination with theophylline poses a risk of unintended medication exposure, which can cause adverse reactions or drug interactions depending on the finished drug product it was used in. Theophylline has a narrow therapeutic range, meaning small amounts can significantly affect a patient's health or interfere with other medications.

What You Should Do

  1. Check your pharmaceutical manufacturing inventory for 30 kg plastic drums of Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized.
  2. Verify if your product matches Batch numbers 18472036 or 18472041, specifically Lot 18472036.
  3. Contact your healthcare provider or pharmacist for guidance if you are a patient concerned about medication made with this excipient. Return any unused product to the pharmacy for a refund and contact BASF Corporation for further instructions.
  4. If you are a manufacturer, immediately stop using the affected batches in production and contact BASF Corporation at their Florham Park, New Jersey office for return or disposal instructions.
  5. For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund

Contact healthcare provider and return product

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund
๐Ÿ“‹Option 2: Other Action

Manufacturer notification

How to: Contact the manufacturer for further instructions regarding the contaminated excipient batches.

Affected Products

Product: Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized (30 kg plastic drums)
Model:
Recall #: D-0149-2021
Lot Numbers:
Batch # 18472036
Batch # 18472041
Lot: 18472036

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86805
Status: Resolved
Manufacturer: BASF Corporation
Sold By: Pharmaceutical manufacturers
Manufactured In: United States, Germany
Units Affected: 4560 kg
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.