Kollidon CL-M Crospovidone Ph — Class II drug recall D-0149-2021
Completed recall by BASF Corporation, reported 2020-12-23, distributed nationwide. Cross contamination: the excipient was found to be contaminated with theophylline.
| Recall number | D-0149-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | BASF Corporation, Florham Park, NJ, United States |
| Recall initiated | 2020-11-17 |
| Classified | 2020-12-15 |
| Reported by FDA | 2020-12-23 |
| Distributed | Nationwide (US) |
| Quantity | 4,560 kilograms |
| Lot numbers | 18472036, 18472041 |
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
Reason for recall
Cross contamination: the excipient was found to be contaminated with theophylline.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0149-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.