Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg — Class II drug recall D-0183-2021
Terminated recall by CIPLA, reported 2021-01-06, distributed nationwide. Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
| Recall number | D-0183-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CIPLA, Warren, NJ, United States |
| Recall initiated | 2020-12-17 |
| Classified | 2020-12-30 |
| Reported by FDA | 2021-01-06 |
| Terminated | 2022-12-07 |
| Distributed | Nationwide (US) |
| Quantity | 6,491 packets |
| NDC | 69097-0528, 69097-0528-34, 69097-0529, 69097-0529-34 |
| Lot numbers | KA00415, KA00416 |
| Expiration dates | 2021-11 |
Product
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 NDC 69097-529-34
Reason for recall
Cross- contamination with other products: The excipient, Crospovidone, NF is 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-0183-2021. 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.