FDA Drug recall D-0181-2021
Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurku…
- FDA Drug
- Class II
- terminated
- Published 2021-01-06
On 2021-01-06 the FDA classified a Class II recall of Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurku… by Cipla, citing cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0181-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-17 |
| Published | 2021-01-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cipla |
| Distribution | US |
Product
Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, 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 69097-527-34
Reason
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Identifiers
| ndc | 69097-527-34 |
|---|---|
| code_info | Lot #: KA00411, KA00412, KA00460, Exp 11/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2022-09-14 · Cipla
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0181-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.