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Drug recall · FDA · Published October 1, 2019

Dr. Reddy's Laboratories, Inc. recalls Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.)

Dr. Reddy's recalls 150mg ranitidine tablets with NDMA impurity detected. Stop using affected batches to avoid potential health risks.

🇺🇸 FDA recall #D-0171-2020DrugDr. Reddy's ›
Take action

Contact the company & request your remedy

Recalling firmDr. Reddy's Laboratories, Inc.107 College Rd E, N/A · Princeton, NJ 08540-6623
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Dr. Reddy's is recalling ranitidine tablets that contain NDMA impurity. This impurity has been detected in the product and may pose health risks, so affected users should stop using the tablets. Read more at govinfonow.com/recall/37873-dr-reddy-s-ranitidine-tablets-recall-ndma-impurity-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/37873-dr-reddy-s-ranitidine-tablets-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0171-2020

Cite this page

“Dr. Reddy's Ranitidine Tablets Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37873-dr-reddy-s-ranitidine-tablets-recall-ndma-impurity-risk. Based on FDA recall #D-0171-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0171-2020%22&limit=1).

Why it’s dangerous

NDMA (N-nitrosodimethylamine) is a potential carcinogen that can form in some medications. The presence of this impurity in ranitidine tablets may increase cancer risk over time with use.

Who’s affected

People who own or use the recalled ranitidine tablets (150mg, 65-count or 130-count bottles) are affected. Those with the tablets may be at risk of health issues due to the impurity.

How to tell if you have this one

Check for 150mg ranitidine tablets in 65-count or 130-count bottles with NDC codes 49035-404-61 or 49035-404-13. These were sold at Walmart and contain all lots within their expiration dates.

  • Brand
    Dr. Reddy's
  • Category
    Drug
FDA recall event · 18 products

All 18 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
    Completed
  • Distribution
    Product was distributed to major distributors throughout the United States who may have further distributed the product.
Recall numberProduct, codes & lotsNDC
D-0168-2020Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05); Batch Numbers: All lots within expiry.55111-129-60, 55111-129-05, 55111-130-30, 55111-130-01
D-0169-2020Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720; Batch Numbers: All lots within expiry.—
D-0170-2020Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) 65 count bottles (NDC 0363-0010-61) , c.) 95 count bottles (NDC 0363-0010-62), d.) 200 count bottles (NDC 0363-0010-01) (Walgreens) OTC; Batch Numbers: All lots within expiry.—
D-0171-2020Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (NDC 49035-404-65) (Walmart) OTC; Batch Numbers: All lots within expiry.—
D-0172-2020Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count bottles (NDC 30142-505-50) (Kroger) OTC; Batch Numbers: All lots within expiry.—
D-0173-2020Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80 count bottles (NDC 69842-871-80) c.)160 count bottles (NDC 69842-871-37) (CVS) OTC; Batch Numbers: All lots within expiry.—
D-0174-2020Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger); Batch Numbers: All lots within expiry.—
D-0175-2020Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC; Batch Numbers: All lots within expiry.—
D-0176-2020Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC.; Batch Numbers: All lots within expiry.—
D-0177-2020Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison) OTC.; Batch Numbers: All lots within expiry.—
D-0178-2020Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.; Batch Numbers: All lots within expiry.—
D-0179-2020Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC.; Batch Numbers: All lots within expiry.—
D-0180-2020Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01); Batch Numbers: All lots within expiry.55111-129-60, 55111-129-05, 55111-130-30, 55111-130-01
D-0181-2020Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC); Batch Numbers: All lots within expiry.55111-131-30, 55111-131-60, 55111-131-80, 55111-131-90, 55111-131-04, 55111-131-37, 55111-131-79, 55111-131-14, 55111-131-81, 55111-131-45
D-0182-2020Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC); Batch Numbers: All lots within expiry.55111-404-34, 55111-404-32, 55111-404-36, 55111-404-50, 55111-404-61, 55111-404-55, 55111-404-62, 55111-404-90, 55111-404-02, 55111-404-65, 55111-404-17, 55111-404-24, 55111-404-38, 55111-404-40
D-0183-2020Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC; Batch Numbers: All lots within expiry.—
D-0184-2020Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC; Batch Numbers: All lots within expiry.—
D-0185-2020Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC; Batch Numbers: All lots within expiry.—
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Tablets Now

    Immediately stop using the recalled ranitidine tablets to avoid potential health risks from NDMA impurity.

✎ GovInfoNow

Questions people ask

What is the NDMA impurity in ranitidine tablets?

NDMA (N-nitrosodimethylamine) is a potential carcinogen that has been detected in the ranitidine tablets.

How can I check if my ranitidine tablets are recalled?

Check for 150mg ranitidine tablets in 65-count or 130-count bottles with NDC codes 49035-404-61 or 49035-404-13. These were sold at Walmart.

Is there a fix for the NDMA impurity?

The recall record does not mention any remedy or fix for the impurity.

Take action

Contact Dr. Reddy's

We’ve drafted a message you can send Dr. Reddy's to request your refund or repair — edit it as you like.

Subject: Recall D-0171-2020 — Dr. Reddy's Dr. Reddy's

Hello,

I own a Dr. Reddy's that is covered by recall D-0171-2020 from Dr. Reddy's.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-0171-2020 (October 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0171-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA