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Zantac Recall: Timeline of Recall and Information on Specific Lots

Many heartburn sufferers have relied on Zantac and other generic ranitidine-containing brands to relieve the burning sensation typically caused by gastroesophageal reflux (GERD). When recent studies linked the over-the-counter (OTC) ranitidine drug to various forms of stomach cancer, the government pulled Zantac from retail shelves in the United States.

Were you diagnosed with Zantac OTC-related cancer, or did you lose a loved one from wrongful death? The personal injury attorneys at Rosenfeld Injury Lawyers, LLC can serve as your legal advocate to help you seek justice and the Zantac lawsuit payout you deserve.

Contact our Zantac cancer attorneys today at (888) 424-5757 (toll-free phone call) or through the contact form to schedule a free consultation. All information you share with our law offices remains confidential through an attorney-client relationship.

For decades, pharmaceutical manufacturers have formulated Zantac to treat various conditions like acid indigestion, heartburn, erosive esophagitis, ulcers, GERD, and sour stomach.

However, in 2020, the U.S. Food and Drug Administration recalled all ranitidine-containing heartburn drug products, including Zantac, due to potential N-Nitrosodimethylamine (NDMA) contamination, a known probable human carcinogen.

Zantac Use Statistics

For years, health care professionals had recommended using ranitidine-containing products, including Zantac, to treat intestinal and stomach ulcers and prevent them from recurring after healing.

The medication was also prescribed to treat specific esophageal (throat) and stomach problems, including Zollinger-Ellison syndrome, GERD, and erosive esophagitis.

  • The Food and Drug Administration first approved Zantac in June 1983 in ranitidine tablet form,
  • Brand-name Zantac (ranitidine) worked by decreasing stomach acid levels, relieving common stomach acid symptoms, including heartburn, stomach pain, coughing, and difficulty swallowing,
  • Most people take Zantac for acid reflux and heartburn problems,
  • Medical science classifies ranitidine, the active ingredient in Zantac, as H2 blockers (antagonists) blocking histamine action in the stomach parietal cell receptors, reducing stomach acid,
  • Ranitidine-containing heartburn medications to treat acid indigestion and heartburn were taken orally, and tablet form, swallowed whole without chewing, followed by a glass of water,
  • Health care professionals recommended taking ranitidine no later than sixty minutes before eating or drinking to prevent acid indigestion and heartburn,
  • Health care professionals typically prescribed Zantac orally at no more than two tablets every twenty-four hours or less if recommended on the product packaging,
  • Zantac OTC ranitidine-containing products and prescription-grade products were not practical for everyone, where a healthcare professional might recommend ceasing its use if heartburn did not improve in the first 14 days,
  • Some health care professionals prescribe ranitidine for the treatment of Zollinger-Ellison syndrome, a rare illness involving a stomach or pancreas tumor,
  • Some people had been taking ranitidine-containing Zantac’s for an extended time, while others found nearly permanent relief over a short time,
  • Zantac’s lowest strength available without a prescription was 75 mg tablets,
  • Zantac could be taken with or without food,
  • The pharmaceutical manufacturer sold numerous ranitidine-containing products, including Zantac, Zantac 75, Zantac 150, Zantac 300, and Zantac 75 Relief (OTC versions and prescriptions,
  • Medication data estimates that healthcare professionals prescribed ranitidine-containing products, like Zantac more than 18,739,600 times in the United States in 2018, up from 14 million prescriptions annually in 2008,
  • Zantac is ranked number forty-one on the list of the most popular medications in the U.S.
  • The average out-of-pocket costs for prescription-grade Zantac is $8.17, which dropped in price significantly from nearly $40 per prescription in 2008,
  • Very few Zantac users develop the known side effects after taking ranitidine products, while others experience constipation, stomach pain, or feeling sick,
  • Many individuals took oral Zantac (ranitidine) to treat or prevent heartburn and other symptoms associated with acid indigestion, typically prescribed by their health care professional,
  • H2 blockers like Zantac work differently than proton pump inhibitors like Prilosec,
  • Before the recall, about 15 million individuals in the U.S. took Zantac or other heartburn ranitidine-containing medications at both prescription strength and over-the-counter doses,
  • For nearly a decade, medical scientists have had concerns over possible cancer-causing impurities found in nearly all ranitidine drugs, including Zantac,
  • The U.S. FDA (Food and Drug Administration) recommends every health care professional prescribing Zantac to find alternative products or consumers to stop taking OTC ranitidine-containing Zantac,
  • The FDA release disposal instructions for all remaining supplies of Zantac and all ranitidine products,
  • Heartburn medications are available in various forms prescribed by a health care professional, including prescription ranitidine tablets, soluble tablets, and liquids,
  • The typical ranitidine medication dose is based on the patient’s condition, including heartburn/indigestion (75mg-300mg daily), esophageal inflammation and stomach ulcers (300mg-600mg daily), and Zollinger-Ellison syndrome (450mg-6g daily)
  • People with kidney issues and children typically took lower doses of Zantac.

Zantac Recall Timeline

The Food and Drug Administration first approved Zantac in 1983 as a short-term treatment for different forms of stomach ulcers. The FDA approved the ranitidine-containing drug that had already been distributed and sold in over thirty countries.

Originally, Glaxo Holdings LTD manufactured Zantac, which became the best-selling medicine globally in 1988, topping over $1 billion in annual sales.

In 1997, the patent for ranitidine, held by Glaxo, expired, allowing competitors to enter the generic alternative drug market. Between 2004 and 2017, the FDA approved Pfizer’s OTC ranitidine-containing Zantac in the United States.

Soon, other companies, including Boehringer Ingelheim Pharmaceuticals, and Johnson & Johnson, launched their generic versions of the over-the-counter medication.

However, concerns over Zantac’s active ingredient ranitidine arose when U.S. and European regulators recalled valsartan, a blood pressure medicine due to contaminated N-nitrosodimethylamine (NDMA) after impurities were found in many samples of the drug.

In response, European and U.S. regulators began reviewing the safety and efficacy of N-nitrosodimethylamine (NDMA) in all medications, including Zantac. By September 2019, a generic Zantac manufacturer Sandoz halted its distribution of Zantac generic versions in every market worldwide.

Ten days later, major US drug store chains, including CVS Health Corps, Walmart, and Rite-Aid, stopped selling their generic versions and removed all Zantac products from their shelves. The recall continued.

  • October 2, 2019 – The FDA announces that it found unacceptable levels of N-nitrosodimethylamine (NDMA) in numerous ranitidine-containing products in random sample testing,
  • October 8, 2019Glaxo SmithKline announces that they are removing brand name Zantac from every market as a precautionary measure,
  • October 18, 2019 – Sanofi recalls Zantac over-the-counter products in Canada and the United States one day after Teva Pharmaceutical (U.K.) recalls numerous batches of ranitidine products,
  • November 1, 2019 – The FDA concludes its NMDA testing of 18 different products finding levels between 0.03 to 2.85 ppm,
  • December 4, 2019 – Instead of removing ranitidine-containing products from the medical marketplace, the FDA recommends manufacturers not sell their products if they contain unacceptable levels of NMDA,
  • January 6, 2020 – Northwind Pharmaceuticals Inc is added to Zantac manufacturers’ voluntarily recall list of their U.S. generic Zantac products,
  • February 27, 2020 – American Health Packaging begins voluntarily recalling Amneal-manufactured ranitidine tablets,
  • April 1, 2020 – Finally, the Food and Drug Administration announced an immediate market withdrawal of all over-the-counter and prescription-grade ranitidine meds.

Zantac Not Suitable for Everyone

Many adults used prescription grade and over-the-counter Zantac products. However, children fifteen years of age and younger required prescription ranitidine drugs only.

The Food and Drug Administration acknowledges that Zantac and ranitidine medicines have specific health risks.

Months ago, the FDA found unacceptable levels of NDMA in ranitidine, a known carcinogenic. However, other contributing factors might not be healthy for every patient or Zantac consumer.

The health care provider would likely not prescribe Zantac if their patient:

  • Was allergic to ranitidine or had a history of allergic reactions to drugs,
  • Had a history of kidney issues,
  • Experienced sugar or fructose intolerance
  • Was following a low-salt or low calcium diet,
  • Could not consume products with alcohol (liquid forms of ranitidine contain tiny amounts of alcohol),
  • Was diagnosed with a potentially severe inherited disorder PKU (Phenylketonuria)

Research evidence shows that many people who took ranitidine-containing products, including Zantac, experienced very few side effects. Stomach pains, constipation, and feeling ill accounted for approximately one out of every 1000 patients.

Severe side effects in taking all ranitidine products like Zantac are even more rare, occurring in fewer than one in 10,000 users. However, severe side effects typically included:

  • Intense stomach pain getting increasingly worse, which might be an indicator of an inflamed pancreas or liver,
  • Urinating pain, fever, back pain, and blood found in the urine that might be an early indicator of kidney problems,
  • Irregular or slow heartbeats,
  • Swollen joints or kidney issues that might be indicative of vasculitis (swollen small blood vessels)

In very rare cases, the Zantac user might develop anaphylaxis, a severe allergic reaction to ranitidine that often involves peeling or blistering skin, wheezing, throat or chest tightness, difficulty talking or breathing, and swollen mouth, tongue, lips, face, and throat.

Specific drugs can have adverse effects when used concomitantly with ranitidine medicines, including Zantac. These drugs include:

  • Itraconazole, Ketoconazole, Posaconazole or other antifungal drugs,
  • HIV medications,
  • Cancer treating drugs,
  • Others

U.S. Food and Drug Administration (FDA) and NDMA

In September 2019, the Food and Drug Administration announced preliminary laboratory test results involving ranitidine containing possible contamination of NDMA, a probable human carcinogen.

Testing ranitidine found unacceptable levels of N-nitrosodimethylamine (NDMA), a member of N-nitrosamines. The toxic substance has been found to produce cancer in laboratory animals.

After the results were released, the FDA did not require discontinuing the product. However, the agency did recommend patients talking with their doctors about using alternative treatments and options.

By April 2020, the FDA requested that all ranitidine-containing products, including Zantac, be removed from store shelves (OTC) and the medical marketplace (prescription grade). After recognizing that the unacceptable levels of NDMA found in all the tested ranitidine samples increased over time when stored higher than room temperatures, the federal government agency made the change.

The U.S. Food and Drug Administration announced its concern for safety with consumers and patients and requested that pharmaceutical manufacturers no longer make ranitidine-containing products available for prescription or over-the-counter use.

Zantac Recall Statistics

  • Approximately 15 million people in the United States are affected by the recent FDA Zantac recall,
  • In September 2019, Sandoz participated in the first voluntary recall, pulling their generic version of Zantac from the medical marketplace,
  • Many other generic manufacturers soon followed Sandoz by voluntarily recalling their ranitidine products,
  • The FDA recalls valsartan in July 2018 due to similar N-Nitrosodimethylamine (NDMA) contamination problems,
  • The Zantac manufacturer Sanofi was slow at voluntarily recalling their heartburn medication, claiming that the levels of NDMA “barely exceed amounts found in common foods.”
  • As Zantac’s marketer, Pfizer also participated in the FDA recall due to NDMA contamination concerns,
  • Data shows that in March 2020, fifteen U.S. heartburn manufacturers recalled their products from the medical marketplace,
  • In the fall of 2019, CVS Pharmacy, Rite-Aid, Walgreens, and Walmart suspended Zantac and generic brand ranitidine-containing heartburn medications,
  • During the investigation, the FDA advised pharmaceutical manufacturers to test every lot of ranitidine-containing products.

Zantac and FDA Medical Director Woodcock

Storage, rather than manufacturing, is a significant concern in medicines manufactured with the active ingredient ranitidine. The FDA believes that probable human carcinogen N-nitrosodimethylamine (NDMA) contamination occurs in ranitidine before consumer use when sold in a prescription form and over-the-counter generic and branded forms of Zantac.

FDA Center for Drug Evaluation Research Medical Director Janet Woodcock stated that “there are still questions about how the impurity is formed in the ranitidine over time during storage.” Woodcock stated that “the testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater level of NDMA.”

The FDA made a market withdrawal request for manufacturers to voluntarily recall their ranitidine-containing products, including Zantac, and provide consumers a drug take-back location to return the product instead of using it.

Bloomberg reports that nearly 45 jurisdictions and countries, including the U.S., have issued bans, warnings, and recalls of ranitidine-containing products, including Austria, Canada, France, Germany, Greece, Indonesia, Ireland, Italy, Japan, Namibia, New Zealand, Norway, South Korea, Taiwan, and United Kingdom.

Drug manufacturers that have participated in the FDA Zantac recall include:

  • American Health Packaging
  • Amneal Pharmaceuticals LLC
  • Apotex Corp. (Rite-Aid, Walmart, and Walgreen brands)
  • Appco Pharma LLC
  • Aurobindo Pharma USA
  • Denton Pharma (d.b.a. Northwind Pharmaceuticals)
  • Dr. Reddy’s Laboratories LTD (CVS, Kroger, Target, Walmart, and Walgreen brands)
  • Glaxo SmithKline
  • Glenmark Pharmaceuticals Inc.
  • Golden State Medical Supply Inc.
  • Lannett Company Inc.
  • Novitium Pharma LLC
  • Perrigo Company PLC
  • Precision Dose Inc.
  • Sandoz
  • Sanofi (brand-name Zantac)

FDA Testing of H2 Blockers (Antagonists)

Results of initial U.S. Food and Drug Administration laboratory tests revealed varying levels of potential N-Nitrosodimethylamine (NDMA) in ranitidine, a known probable human carcinogen in heartburn drug products manufactured by different companies, including:

  • Ajanta Pharma USA Inc
  • Amneal Pharmaceuticals
  • Aurobindo
  • Cardinal Health
  • Dr. Reddy’s
  • Novitium
  • Pharma Associates
  • Sandoz
  • Sanofi Pharmaceutical
  • Silarx Pharma
  • Strides Shasun Ltd
  • Watson

The federal government agency continued investigating NDMA in ranitidine exposure in heartburn products well into September 2019, warning the public of the potential cancer risks and urging consumers and patients to use other products and treatments.

By April 2020, the FDA announced additional research results that raised concerns that using Zantac and other ranitidine-containing drugs exposed the public to unacceptable levels of a toxic substance called n-nitrosodimethylamine (NDMA) due to cancer risk.

NDMA-Related Injuries

The National Institute of Health, FDA, and CDC have found numerous cancers linked to NDMA exposure that including cancer of the:

  • Bladder
  • Breast
  • Colon
  • Esophagus
  • Intestines
  • Kidneys
  • Liver
  • Lungs
  • Pancreas
  • Prostate

American Health Packaging Recalled Lots

The company began recalling Zantac lots in November 2019, including their ranitidine-containing syrup (150 mg/10 mL) due to trace amounts of detected NMDS. Their lots include:

  • 177874
  • 178413
  • 183449
  • 183723
  • 184278
  • 184445
  • 186563
  • 187652

Amneal Recalled Lots

In November 2019, Amneal Pharmaceuticals LLC voluntarily recalled their generic Zantac versions due to unacceptable contamination levels and numerous products, including ranitidine syrup (50 mg/mL) and ranitidine tablets (150 mg & 300 mg). Their recalled lots include:

  • 53746-253-10
  • 53746-254-02
  • 65162-253-06
  • 65162-253-10
  • 65162-253-11
  • 65162-253-18
  • 65162-253-50
  • 65162-254-03
  • 65162-254-10
  • 65162-254-25
  • 65162-664-90

Apotex Recalls

In September 2019, Apotex recalled their generic versions of Zantac from store shelves, including Rite-Aid, Walmart, Walgreens, selling 750 mg and 150 mg tablets of store brand ranitidine. The Apotex recalled lots involving NDMA contamination concerns include:

  • 0363-1013-02
  • 0363-1029-03
  • 0363-1030-06
  • 0363-1030-07
  • 0363-1030-09
  • 11822-4727-3
  • 11822-6051-8
  • 11822-6052-1
  • 11822-6052-2
  • 11822-6107-4
  • 49035-100-00
  • 49035-100-07
  • 49035-117-06

Appco Recall Lots

In January 2020, Appco joined other pharmaceutical companies in voluntarily recalling ranitidine-containing products due to NDMA contamination concerns, including eight lots of their ranitidine (150 mg & 300 mg) capsules.

  • 1905225VN
  • 1905226VD
  • 1905227UE
  • 1905228UE
  • 1906295UN
  • 1906296UN
  • 1906297UN
  • 1906298UD

Aurobindo Pharma USA Recalls

In November 2019, Aurobindo agreed to follow the recommended FDA voluntary recall after the pharmaceutical company indicated they had detected NDMA contamination in their products, including ranitidine 150 mg tablets (1 lot), 150 mg/300 mg capsules (37 lots), and ranitidine syrup (50 mg/mL).

Glenmark Pharmaceuticals Inc. Recalled Lots

In December 2019, Glenmark initiated an FDA-recommended voluntary recall of over 900 expired lots of 150 mg & 300 mg ranitidine tablets that contained or might contain toxic levels of NDMA. Their lots involving NDMA contamination concerns include:

  • 684620-248-60
  • 684620-248-01
  • 684620-248-05
  • 684620-249-30
  • 684620-249-01
  • 684620-249-20

Golden State Medical Supply Inc. Recalls

In November 2019, Golden State Medical Supply initiated a recall of its ranitidine HCI 150 mg capsules (7 lots) and ranitidine HCI 300 mg capsules (12 lots). The company stated that the recalled lots had been sold to Tricare Mail Order Pharmacies, McKesson, and Amerisource Bergen.

Lannett Company Inc. Recalls

In September 2019, the company began testing its ranitidine syrup products for contamination in its active pharmaceutical agreement. A presence of toxic NDMA was found in the testing results.

In response, the company initiated a recall in October 2019 according to FDA recommendations on all products expiring between October 2019 and August 2021 (NDC code 54838-550-80).

Northwind Pharmaceuticals (Denton Pharma) Recalled Lots

In January 2020, the company initiated a voluntary recall of their 150 mg & 300 mg prescription ranitidine tablets, including seven lots repackaged and sold to Crosswind Pharmacy. Their lots involving NDMA concerns include:

  • 70934-017-04
  • 70934-017-20
  • 70934-017-24
  • 70934-017-30
  • 70934-017-90
  • 70934-287-15
  • 70934-287-90

Novitium Pharma LLC Recalls

In October 2019, the company announced it would initiate a recall of all lots in quantities of their prescription ranitidine products, including the NDMA contaminated lots:

  • 70954-001-20
  • 70954-001-40
  • 70954-002-10
  • 70954-002-40

Perrigo Company PLC Recalls

In October 2019, the company followed recommendations by the U.S. Food and Drug Administration (FDA), initiating a worldwide voluntary recall of all package sizes and lots, pulling their ranitidine medications from consumer shelves.

Before announcing the recall involving NDMA concerns, the company had already halted shipments of newly manufactured products.

Precision Dose Recall Lots

The company responded to Amneal Pharmaceuticals recall and initiated their voluntary FDA-recommended recall of prescription ranitidine 150 mg/10 mL oral solution (five lots) that include:

  • 501290
  • 501326
  • 501501
  • 501592
  • 501679

Reddy’s Laboratories LTD Recalls

In October 2019, Dr. Reedy’s Laboratories initiated a voluntary recall on its OTC and prescription ranitidine medications sold at numerous retailers, including Walgreens, CVS, Walmart, Sam’s Club, and Target.
Their recall included ranitidine tablets (75 mg, 150 mg, & 300 mg) in 24 to 500 packs involving NDMA cancer risk.

Sandoz Recalls

In September 2019, Sandoz initiated a voluntary recall of its 150 mg & 300 mg ranitidine drugs, including 20, 60, & 500 count bottles. Sandoz recalled lots involving NDMA cancer risk concerns include:

  • HD1862
  • HP9438
  • HP9439
  • HP9440
  • HC9266
  • HD1865
  • HP9441
  • JK7994
  • JK8659
  • HD8625
  • HD9275
  • HU2207
  • HX6676
  • HX6677

Don’t Be a Statistic. Hire a Zantac Cancer Attorney Today to Handle Your Compensation Case

Were you recently diagnosed with cancer or other chronic condition related to Zantac use, or did you lose a loved one through a wrongful death caused by NDMA contamination? The personal injury attorneys at Rosenfeld Injury Lawyers, LLC can help.

Plaintiffs have filed Zantac lawsuits against the manufacturer and marketer of the ranitidine-containing product, Sanofi and Pfizer, claiming that both companies failed to warn the public of the increased risk of cancer caused by NDMA contaminated ranitidine.

Contact our contaminated ranitidine injury lawyers today at (888) 424-5757 (toll-free phone call) or through the contact form to schedule a free consultation. All information you share with our law offices remains confidential through an attorney-client relationship.

Our law firm currently follows CDC (Centers for Disease Control and Prevention) Covid-19 (coronavirus) social distancing guidelines to protect our clients.

Resources:

Food and Drug Administration Press Release – Zantac Removal from the Market
GI & Hematology News – FDA Calls for Zantac (Ranitidine) Removal