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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

Dr. Reddy's Laboratories, Inc.: Ranitidine Capsules and Tablets Recalled for NDMA Impurity

Agency Publication Date: November 5, 2019
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Summary

Dr. Reddy's Laboratories is recalling numerous lots of generic Zantac, known as Ranitidine (150 mg and 300 mg capsules and tablets), sold under various brand names such as Walgreens, Walmart, CVS, and Target. The recall was initiated because testing detected the presence of N-Nitrosodimethylamine (NDMA), an impurity that is classified as a probable human carcinogen. Consumers should contact their healthcare provider or pharmacist to discuss alternative treatments and return any unused medication to the pharmacy for a refund.

Risk

The medication contains NDMA, a substance that may cause cancer in humans based on laboratory testing. Long-term exposure to levels above acceptable limits increases the risk of developing cancer.

What You Should Do

  1. Check your medicine cabinet for Ranitidine 150 mg or 300 mg capsules or tablets from brands including Dr. Reddy's, Walgreens, Walmart (Equate), Sam's Club (Member's Mark), Kroger, CVS, CDMA (Quality Choice), HCA, Thirty Madison (Keeps), GeriCare, or Target (Up & Up).
  2. Identify affected products by checking for 'All lots within expiry' across many NDC numbers, such as 55111-129-60, 150062076 (UPC 078742089720), 0363-0010-34, 49035-404-61, 30142-505-34, 69842-871-30, and others listed in the recall.
  3. If you are taking the prescription version (Rx), contact your healthcare provider for a replacement or alternative treatment before you stop taking the medication.
  4. If you are using the over-the-counter (OTC) version, stop using the product and consider using other OTC products approved for your condition.
  5. Return any unused portions of the recalled medication to the place of purchase for a refund.
  6. Contact Dr. Reddy's Laboratories, Inc. at 1-888-723-3332 or visit www.drreddys.com for more information regarding this recall.
  7. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

๐Ÿ’ฐFull Refund

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

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

Affected Products

Product: Dr. Reddy's Ranitidine Capsules 150 mg (60 and 500 count)
Model:
NDC 55111-129-60
NDC 55111-129-05
Lot Numbers:
All lots within expiry
Product: Sam's Club Ranitidine Tablets, USP 150 mg (190 count)
Model:
NDC 150062076
UPC Codes:
078742089720
Lot Numbers:
All lots within expiry
Product: Walgreens Ranitidine Tablets, USP 150 mg (24, 65, 95, 200 count)
Model:
NDC 0363-0010-34
NDC 0363-0010-61
NDC 0363-0010-62
NDC 0363-0010-01
Lot Numbers:
All lots within expiry
Product: Walmart Ranitidine Tablets, USP 150 mg (65, 130, 220 count)
Model:
NDC 49035-404-61
NDC 49035-404-13
NDC 49035-404-65
Lot Numbers:
All lots within expiry
Product: Kroger Ranitidine Tablets, USP 150 mg (24, 50 count)
Model:
NDC 30142-505-34
NDC 30142-505-50
Lot Numbers:
All lots within expiry
Product: CVS Ranitidine Tablets, USP 75 mg (30, 80, 160 count)
Model:
NDC 69842-871-30
NDC 69842-871-80
NDC 69842-871-37
Lot Numbers:
All lots within expiry
Product: Kroger Ranitidine Tablets, USP 75 mg (30 count)
Model:
NDC 30142-131-30
Lot Numbers:
All lots within expiry
Product: CDMA Ranitidine Tablets 75 mg (30, 60 count)
Model:
NDC 63868-482-30
NDC 63868-482-60
Lot Numbers:
All lots within expiry
Product: HCA Ranitidine Tablets, USP 150 mg (95, 220 count)
Model:
NDC 43598-808-62
NDC 43598-808-65
Lot Numbers:
All lots within expiry
Product: Thirty Madison Ranitidine Tablets, USP 150 mg (24, 95 count)
Model:
NDC 71713-203-02
NDC 71713-203-05
Lot Numbers:
All lots within expiry
Product: GeriCare Ranitidine Tablets, USP 75 mg
Model:
NDC 57896-715
Lot Numbers:
All lots within expiry
Product: Target Ranitidine Tablets, USP 150 mg (40 count)
Model:
NDC 11673-849-40
Lot Numbers:
All lots within expiry
Product: Dr. Reddy's Ranitidine Capsules, USP 300 mg (30, 100 count)
Model:
NDC 55111-130-30
NDC 55111-130-01
Lot Numbers:
All lots within expiry
Product: Dr. Reddy's Ranitidine Tablets, USP 75 mg (60 count)
Model:
NDC 55111-131-60
Lot Numbers:
All lots within expiry
Product: Dr. Reddy's Ranitidine Tablets, USP 150 mg (24 count)
Model:
NDC 55111-404-34
Lot Numbers:
All lots within expiry
Product: Walgreens Ranitidine Tablets, USP 75 mg (30, 80 count)
Model:
NDC 0363-0131-30
NDC 0363-0131-80
Lot Numbers:
All lots within expiry
Product: CDMA Ranitidine Tablets, USP 150 mg (24, 50 count)
Model:
NDC 63868-480-24
NDC 63868-480-50
Lot Numbers:
All lots within expiry
Product: GeriCare Ranitidine Tablets, USP 150 mg
Model:
NDC 57896-717
Lot Numbers:
All lots within expiry

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83908
Status: Resolved
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: Sam's Club; Walgreens; Walmart; Kroger; CVS; CDMA; HCA; Thirty Madison; GeriCare; Target
Manufactured In: United States
Distributed To: Nationwide
Agency Last Updated: December 3, 2019

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.