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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

CIPLA: Esomeprazole Magnesium Oral Suspension Recalled for Theophylline Contamination

Agency Publication Date: December 30, 2020
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Summary

Cipla is recalling 580,451 packets of Esomeprazole Magnesium for Delayed-Release Oral Suspension (generic Nexium) in 10mg, 20mg, and 40mg doses. These prescription medications are being recalled because an inactive ingredient used during manufacturing was found to be contaminated with theophylline, an unrelated drug used to treat respiratory diseases. Consumers should contact their doctor or pharmacist immediately as taking this contaminated medication may lead to unintended side effects or drug interactions.

Risk

The product is contaminated with theophylline, a drug used for asthma and COPD. This cross-contamination can cause adverse health effects if consumers unknowingly ingest theophylline along with their prescribed esomeprazole.

What You Should Do

  1. Check your medication packets for Esomeprazole Magnesium for Delayed-Release Oral Suspension in 10mg, 20mg, or 40mg strengths manufactured for Cipla USA.
  2. Identify if your packets belong to the affected lots: for 10mg, check for Lot # KA00411, KA00412, or KA00460; for 20mg, check for Lot # KA00413, KA00414, or KA00461; for 40mg, check for Lot # KA00415 or KA00416. All affected lots have an expiration date of 11/2021.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking the medication.
  4. Return any unused packets to your pharmacy to receive a refund.
  5. Contact Cipla USA, Inc. at 10 Independence Boulevard, Suite 300 Warren, NJ 07059 for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Esomeprazole Magnesium for Delayed-Release Oral Suspension (10mg)
Model:
NDC 69097-527-34
Recall #: D-0181-2021
Lot Numbers:
KA00411 (Exp 11/2021)
KA00412 (Exp 11/2021)
KA00460 (Exp 11/2021)
Date Ranges: Expiration Date: 11/2021
Product: Esomeprazole Magnesium for Delayed-Release Oral Suspension (20mg)
Model:
NDC 69097-528-34
Recall #: D-0182-2021
Lot Numbers:
KA00413 (Exp 11/2021)
KA00414 (Exp 11/2021)
KA00461 (Exp 11/2021)
Date Ranges: Expiration Date: 11/2021
Product: Esomeprazole Magnesium for Delayed-Release Oral Suspension (40mg)
Model:
NDC 69097-529-34
Recall #: D-0183-2021
Lot Numbers:
KA00415 (Exp 11/2021)
KA00416 (Exp 11/2021)
Date Ranges: Expiration Date: 11/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87038
Status: Resolved
Manufacturer: CIPLA
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 3 products (284,610 packets; 289350 packets; 6,491 packets)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.