CLASS II Drug recall · Reported 6 Jan 2021 · FDA Enforcement Report
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg recalled
Cipla is recalling Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, distributed nationwide in the US. The recall was initiated on 17 Dec 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0183-2021
- FDA event ID
- 87038
- Recalling firm
- Cipla, Warren, NJ
- Manufacturer
- Cipla USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2020
- FDA classified
- 30 Dec 2020
- Reported
- 6 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 17 Dec 2020 | Recall initiated by company | |
| 30 Dec 2020 | Classified by FDA | +13 days |
| 6 Jan 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Which lots are affected?
Lot #: KA00415, KA00416, Exp 11/2021
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 87038| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg recalledEsomeprazole Magnesium | Cipla | Packaging Defects | Nationwide | |
| CLASS II | Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg recalledEsomeprazole Magnesium | Cipla | Packaging Defects | Nationwide |
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Other Esomeprazole recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium | Zydus Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg recalledEsomeprazole Magnesium | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg recalledEsomeprazole Magnesium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |