Kollidon CL-M Crospovidone (BASF) – Cross Contamination (2020)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
BASF Corporation
Lot Codes / Batch Numbers
Batch # 18472036, 18472041.
Products Sold
Batch # 18472036, 18472041.
BASF Corporation is recalling Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, M due to Cross contamination: the excipient was found to be contaminated with theophylline.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Cross contamination: the excipient was found to be contaminated with theophylline.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026