Use caution Drug recall · FDA · Published December 17, 2020

Cipla Recalls Esomeprazole Magnesium Due to Contamination

Cipla recalls unit dose packets of Esomeprazole Magnesium 40mg due to cross-contamination with theophylline. Check your lot numbers and expiration date.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0183-2021Drug Cipla ›

Use caution until it’s fixed

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

Take action

Contact the company

Recalling firmCIPLA10 Independence Blvd · Warren, NJ 07059-2730

✎ GovInfoNow plain-language explainer

Cipla Ltd. is recalling Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg because the excipient Crospovidone was contaminated with theophylline. The affected product consists of unit dose packets distributed nationwide in the U.S.A. This recall involves specific lots with an expiration date of November 2021. Read more at govinfonow.com/recall/36585-cipla-recalls-esomeprazole-magnesium-due-to-contamination.

Source Summary by GovInfoNow · govinfonow.com/recall/36585-cipla-recalls-esomeprazole-magnesium-due-to-contamination · Updated October 11, 2026 · FDA enforcement record: FDA #D-0183-2021

Cite this page

“Cipla Recalls Esomeprazole Magnesium Due to Contamination.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36585-cipla-recalls-esomeprazole-magnesium-due-to-contamination. Based on FDA recall #D-0183-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0183-2021%22&limit=1).

Cipla recalled Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg due to cross-contamination with theophylline, according to the FDA on Dec. 17, 2020. The agency announced the Class II recall of 6,491 packets distributed nationwide.

How to tell if you have it

Brand: Cipla
Product: Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg
Packaging: Unit dose packets, Rx only
NDC: 69097-529-34
Lot codes: KA00415, KA00416
Expiration date: 11/2021
Quantity: 6,491 packets

The hazard

The excipient Crospovidone, NF in the product is contaminated with theophylline. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Cipla has issued seven other recalls since Dec. 14, 2020. Recent similar recalls include Cipla Arformoterol Inhaler and Budesonide Inhaler recalls in September 2022 due to sterility risks, and a Difluprednate Eye Drops recall on Aug. 22, 2022 for potential contamination. Other recent recalls of similar products include Cipla Fosfomycin Tromethamine Granules (Sept. 18, 2026), Cinacalcet Tablets (March 16, 2026), and Diclofenac Gel (Dec. 22, 2025).

How to tell if you have this one

Look for unit dose packets of Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg manufactured by Cipla Ltd. in India for Cipla USA, Inc. Check the NDC 69097-529-34 and verify if your lot number is KA00415 or KA00416 with an expiration date of 11/2021.

Brand
Cipla
Category
Drug

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
U.S.A. Nationwide

Recall number	Product, codes & lots	Quantity	NDC
D-0181-2021	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; Lot #: KA00411, KA00412, KA00460, Exp 11/2021	284,610 packets	69097-527-34
D-0182-2021	Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, 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 69097-528-34; Lot #: KA00413, KA00414, KA00461, Exp 11/2021	289350 packets	69097-528-34, 69097-529-34
D-0183-2021	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; Lot #: KA00415, KA00416, Exp 11/2021	6,491 packets	69097-528-34, 69097-529-34

Based on the official FDA remedy

What to do — step by step

Check Your Lot Numbers
Verify if your unit dose packets have lot numbers KA00415 or KA00416 and an expiration date of November 2021.
Contact Your Pharmacist
If you have the recalled product, contact your pharmacist or healthcare provider for instructions on how to proceed.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “U.S.A. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

Dec 17, 2020Firm started the recall
Dec 30, 2020FDA classified it Class II
Jan 6, 2021Published in FDA’s Enforcement Report
Dec 7, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/36585-cipla-recalls-esomeprazole-magnesium-due-to-contamination">Cipla Recalls Esomeprazole Magnesium Due to Contamination (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0183-2021 (December 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0183-2021 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.