Severity
Moderate
ModerateClass IICompleted
FDA Drug recall · Reported December 23, 2020
Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden
Cross contamination: the excipient was found to be contaminated with theophylline.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Basf Corporation recalled Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plast… - a moderate-severity action.
Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plast… was recalled by Basf Corporation in December 23, 2020. Reason: Cross contamination: the excipient was found to be contaminated with theophylline.. Check the official notice for the remedy. Verify recall #D-0149-2021 with the FDA Drug before acting.
The recall
Basf Corporation issued this moderate-severity FDA Drug recall-Cross contamination: the excipient was found to be contaminated with theophylline..
- Moderate
- severity level
- Class II
- classification
- December 23, 2020
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0149-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0149-2021) was formally reported on December 23, 2020, with the manufacturer initiating the action on November 17, 2020. It is classified under Moderate severity (Class II), with a current status of Completed. Basf Corporation is listed as the recalling firm, operating out of Florham Park, NJ. Federal records list the affected scope as 4560 kg.
The documented reason for this recall is: Cross contamination: the excipient was found to be contaminated with theophylline. Distribution data in the federal record shows the product reached: USA Nationwide and Worldwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4560 kg
Related Recalls
6
5 from same agency
Product description
Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden
Reason for recall
Cross contamination: the excipient was found to be contaminated with theophylline.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Completed |
| Recall number | D-0149-2021 |
| Date reported | December 23, 2020 |
| Date initiated | November 17, 2020 |
| Recalling firm | Basf Corporation |
| Firm location | Florham Park, NJ |
| Affected scope | 4560 kg |
| Distribution | USA Nationwide and Worldwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0149-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden. Recalled by Basf Corporation. Units affected: 4560 kg.
Why was this product recalled? ▼
Cross contamination: the excipient was found to be contaminated with theophylline.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 23, 2020. Severity: Moderate. Recall number: D-0149-2021.
Where was the recalled product distributed? ▼
Distribution: USA Nationwide and Worldwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0149-2021) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported December 23, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.