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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

Glenmark Pharmaceuticals Inc., USA: Ranitidine Tablets Recalled Due to Potential NDMA Impurity

Agency Publication Date: January 5, 2020
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Summary

Glenmark Pharmaceuticals Inc., USA is voluntarily recalling approximately 4,048,740 bottles of Ranitidine Tablets (both 150 mg and 300 mg strengths) after tests detected a nitrosamine impurity called N-Nitrosodimethylamine (NDMA) in the product. Ranitidine is a prescription medication used to treat stomach ulcers, gastroesophageal reflux disease (GERD), and conditions where the stomach makes too much acid. These products were manufactured in India and distributed nationwide across the United States. Consumers should consult their healthcare provider for alternative treatment options and instructions on how to safely return the affected medication.

Risk

NDMA is classified as a probable human carcinogen, meaning it is a substance that could cause cancer. This recall was initiated because the tablets contain levels of NDMA that exceed the limits established by the FDA.

What You Should Do

  1. Identify your medication by checking the brand name (Glenmark Ranitidine Tablets USP) and the dosage strength (150 mg or 300 mg) on the label.
  2. Check the bottle size and NDC number. Affected 150 mg bottles include 60-count (NDC 68462-248-60), 100-count (NDC 68462-248-01), and 500-count (NDC 68462-248-05). Affected 300 mg bottles include 30-count (NDC 68462-249-30), 100-count (NDC 68462-249-01), and 250-count (NDC 68462-249-20).
  3. Verify the lot number on the side or bottom of your bottle against the extensive list of over 500 affected codes, such as 19190289, 7701164A, 7701033A, or 7701429A.
  4. Contact your healthcare provider or pharmacist immediately to discuss your treatment. Do not stop taking your prescription medication without first talking to a doctor, as there may be risks to stopping treatment suddenly.
  5. Return any unused medication to the pharmacy where you purchased it for a refund and further guidance on disposal.
  6. Contact Glenmark Pharmaceuticals Inc., USA at 1-888-723-3332 if you have specific questions regarding this recall or the return process.
  7. For additional questions, call 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

Pharmaceutical guidance and partial/full refund through pharmacy return.

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

Affected Products

Product: Glenmark Ranitidine Tablets USP 150 mg Rx Only (60 Tablets)
Model:
NDC 68462-248-60
Lot Numbers:
7701164A
7701471A
7701670B
7701827A
7702242A
7702705A
7702947A
7703408A
7704494A
7704495A
19190289
19190342
19190372
7702737A
Product: Glenmark Ranitidine Tablets USP 150 mg Rx Only (100 Tablets)
Model:
NDC 68462-248-01
Lot Numbers:
7701033A
7701826A
7702344A
7702345A
7702489A
7702706A
7702707A
7702708A
7702858A
7702859A
7702860A
7702928A
7702929A
7703196A
7703634A
7704492A
7704493A
7705159A
19190289
19190342
19190372
Product: Glenmark Ranitidine Tablets USP 300 mg Rx Only (30 Tablets)
Model:
NDC 68462-249-30
Lot Numbers:
7701429A
7701522A
7702255A
7704745A
19190456
19190472
19190490
Product: Glenmark Ranitidine Tablets USP 300 mg Rx Only (100 Tablets)
Model:
NDC 68462-249-01
Lot Numbers (144):
7701030A
7701031A
7701062A
7701063A
7701110A
7701111A
7701112A
7701185A
7701186A
7701187A
7701188A
7701189A
7701269A
7701270A
7701278A
7701279A
7701386A
7701400A
7701401A
7701406A
7701421A
7701434A
7701435A
7701436A
7701452A
7701453A
7701521A
7701522B
7701553A
7701554A
7701555A
7701556A
7701582A
7701817A
7701828A
7701829A
7702001A
7702002A
7702003A
7702012A
7702026A
7702027A
7702064A
7702140A
7702253A
7702254A
7702285A
7702286A
7702287A
7702288A
Product: Glenmark Ranitidine Tablets USP 300 mg Rx Only (250 Tablets)
Model:
NDC 68462-249-20
Lot Numbers (138):
7701069A
7701070A
7701084A
7701085A
7701087A
7701094A
7701095A
7701140A
7701141A
7701142A
7701157A
7701162A
7701182A
7701217A
7701218A
7701219A
7701236A
7701237A
7701220A
7701456A
7701470A
7701520A
7701671A
7701696A
7701697A
7701698A
7701797A
7701928A
7701929A
7701942A
7701943A
7702065A
7702066A
7702067A
7702095A
7702096A
7702097A
7702098A
7702188A
7702189A
7702190A
7702196A
7702197A
7702198A
7702199A
7702348A
7702338A
7702347A
7702349A
7702350A
Product: Glenmark Ranitidine Tablets USP 150 mg Rx Only (500 Tablets)
Model:
NDC 68462-248-05
Lot Numbers (616):
7701034A
7701057A
7701058A
7701059A
7701060A
7701061A
7701071A
7701072A
7701073A
7701074A
7701105A
7701106A
7701107A
7701108A
7701109A
7701113A
7701114A
7701115A
7701116A
7701121A
7701122A
7701123A
7701124A
7701125A
7701126A
7701151A
7701152A
7701165A
7701154A
7701155A
7701163A
7701176A
7701190A
7701221A
7701222A
7701223A
7701224A
7701225A
7701235A
7701253A
7701254A
7701255A
7701256A
7701257A
7701258A
7701259A
7701266A
7701267A
7701268A
7701273A

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84516
Status: Active
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Sold By: Authorized pharmacies; healthcare providers
Manufactured In: India
Units Affected: 6 products (208,668 bottles; 217,956 bottles; 98,988 bottles; 1,309,536 bottles; 500,960 bottles; 1,712,632 bottles)
Distributed To: Nationwide
Agency Last Updated: January 21, 2020

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.