Recent Voluntary Drug Recalls

Ranitidine capsules, tablets and oral solution for the treatment of GERD, heartburn, and ulcer

November 14, 2019  

Commercial and Tufts Health Direct plans

On October 23 & 25, 2019 and November 12, 2019, Amneal Pharmaceuticals, LLC., Aurobindo Pharma USA, Inc.,  Dr. Reddy’s Laboratories Ltd., Lannett Company, Inc., and Novitium Pharma, manufacturers of ranitidine, issued a voluntary recall of ranitidine capsules, oral solution and tablets. This recall was issued because an unexpected impurity was found in these products that may cause health risks.

What do you need to do?

  • Do not stop taking your medication without speaking with your doctor.  The U.S. Food and Drug Administration (FDA) recommends that patients continue taking their medication, as the risk of harm to a patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
  • Please call your doctor right away to obtain a new prescription for another appropriate medication. Your doctor will be able to prescribe another medication for you so you can continue treating your condition without interruption

For more information or to report any adverse events or quality problems experienced with the use of this product directly to Dr. Reddy’s Laboratories Ltd., Lannett Company, Inc., Novitium Pharma., or to the FDA's MedWatch Program:

Manufacturers:

  • Amneal: Call Stericycle 866-918-8768, Monday – Friday, 8:00 am – 5:00 pm, EST
  • Aurobindo Pharma USA, Inc. at 1-866-850-2876, option 2 or via email at pvg@aurobindousa.com
  • Dr. Reddy’s Laboratories Ltd. Medical Information Call Center at 1-888-375-3784, available Monday through Friday 8 a.m. – 8 p.m. EST.
  • Lannett Company, Inc. direct at 215-333-9000, extension 4 or via email at customerservice@lannett.com.
  • Novitium Pharma direct at 609-469-5920, or via email at  info@novitiumpharma.com.

To report an adverse event to the FDA Med Watch Program:

Affected NDCs

Dr. Reddy’s Laboratories Ltd Voluntarily Recalled Products:

Description Strength Type Pack NDC
Ranitidine Capsules 150mg, 60 150 mg Rx 60 ct bottle 5511112960
Ranitidine Capsules 150mg, 500 150 mg Rx 500 ct bottle 5511112905
Ranitidine Capsules 300mg, 30 300 mg Rx 30 ct bottle 5511113030
Ranitidine Capsules 300mg, 100 300 mg Rx 100 ct bottle 5511113001
Rantidine Tablets, USP 150mg,190(2x95)Tray (Sam’s Club) 150 mg OTC 190 ct (2x95) tray 150062076
Ranitidine Tablets, USP 150mg, 95 (Walgreens) 150 mg OTC 95 ct bottle 0363-0010-62
Ranitidine Tablets, USP 150 mg 220 CT Btl (Walmart) 150 mg OTC 220 ct bottle 49035-404-65
Ranitidine Tablets, USP 150mg 50ct Btl (Kroger) 150 mg OTC 50 ct bottle 30142-505-50
Ranitidine Tablets, USP 150mg 24ct Btl (Kroger) 150 mg OTC 24 ct bottle 30142-505-34
Ranitidne Tablets, USP 150mg 65 Ct Btl (Walgreens) 150 mg OTC 65 ct bottle 0363-0010-61
Ranitidine Tablets, USP 150 TAB 65ct BTL CP32 (Walmart) 150 mg OTC 65 ct bottle 49035-404-61
Ranitidine Tablets, USP 150 Tab 200Ct Btl (Walgreens) 150 mg OTC 200 ct bottle 0363-0010-01
Ranitidine Tablets, USP 150mg Tabs Btl, 24 (Walgreens) 150 mg OTC 24 ct bottle 0363-0010-34
Ranitidine Tablets, USP 75 TAB 30ct Bottle NG (CVS) 75 mg OTC 30 ct bottle 69842-871-30
Ranitidine Tablets, USP 75mg Tab 30Ct Btl (Walgreens) 75 mg OTC 30 ct bottle 0363-0131-30
Ranitidine Tablets, USP 75mg Tab 80Ct Btl (Walgreens) 75 mg OTC 80 ct bottle 0363-0131-80
Ranitidine Tablets, USP 75 TAB 80ct Bottle NG (CVS) 75 mg OTC 80 ct bottle 69842-871-80
Ranitidine Tablets, USP 75 TAB 160ct Bottle NG (CVS) 75 mg OTC 160 ct bottle 69842-871-37
Ranitidine Tablets, USP 75mg 30ct Btl (Kroger) 75 mg OTC 30 ct bottle 30142-131-30
Ranitidine Tablets, USP 150 TAB 24ct BTL (CDMA) 150 mg OTC 24 ct bottle 63868-480-24
Ranitidine Tablets, USP 150 Tablet 130ct Bottle NV (Walmart) 150 mg OTC 130 ct bottle 49035-404-13
Ranitidine Tablets, USP 150 TAB 50ct BTL (CDMA) 150 mg OTC 50 ct bottle 63868-480-50
Ranitidine Tablets, USP 75 Tab 60ct Btl (Dr. Reddy’s) 75 mg OTC 60 ct bottle 55111-131-60
Ranitidine Tablets, USP 75 TAB 60ct BTL (CDMA) 75 mg OTC 60 ct bottle 63868-482-60
Ranitidine Tablets, USP 75 TAB 30ct BTL (CDMA) 75 mg OTC 30 ct bottle 63868-482-30
Ranitidine Tablets, USP 150mg Tablets 24ct BTL00 (Dr. Reddy’s) 150 mg OTC 24 ct bottle 55111-404-34
Ranitidine Tablets, USP 150 Tab 95ct Btl (HCA) 150 mg OTC 95 ct bottle 43598-808-62
Ranitidine Tablets, USP 150 Tab 220ct Btl (HCA) 150 mg OTC 220 ct bottle 43598-808-65
Ranitidine Tablets, USP Tab 150mg 40ct Bottle (Target) 150 mg OTC 40 ct bottle 11673-849-40
Ranitidine Tablets, USP 150 Tab 24ct Btl (Thirty Madison) 150 mg OTC 24 ct bottle 71713-203-02
Ranitidine Tablets, USP 150 Tab 95ct Btl (Thirty Madison) 150 mg OTC 95 ct bottle 71713-203-05
Ranitidine Tablets, USP 75mg  (GeriCare) 75 mg OTC All counts 57896-715
Ranitidine Tablets, USP 150mg (GeriCare) 150 mg OTC All counts 57896-717


Lannett Company, Inc. Voluntarily Recalled Ranitidine Syrup (oral solution) 15mg/mL:

NDC Code Batch Expiration Date (Month/Year) NDC Code Batch Expiration Date (Month/Year)
54838-550-80 1503A Oct-19 54838-550-80 1646A Feb-20
54838-550-80 1504A Oct-19 54838-550-80 1647A Feb-20
54838-550-80 1505A Oct-19 54838-550-80 1668A Mar-20
54838-550-80 1523A Oct-19 54838-550-80 1669A Mar-20
54838-550-80 1524A Oct-19 54838-550-80 1670A Mar-20
54838-550-80 1525A Nov-19 54838-550-80 1708A Mar-20
54838-550-80 1561A Dec-19 54838-550-80 1709A Apr-20
54838-550-80 1562A Dec-19 54838-550-80 1710A Apr-20
54838-550-80 1563A Dec-19 54838-550-80 1729A Apr-20
54838-550-80 1589A Dec-19 54838-550-80 1730A Apr-20
54838-550-80 1590A Dec-19 54838-550-80 1731A Apr-20
54838-550-80 1591A Dec-19 54838-550-80 1757A May-20
54838-550-80 1614A Jan-20 54838-550-80 1758A May-20
54838-550-80 1615A Jan-20 54838-550-80 1759A May-20
54838-550-80 1617A Jan-20 54838-550-80 1773A Jun-20
54838-550-80 1644A Feb-20 54838-550-80 1774A Jun-20
54838-550-80 1775A Jun-20 54838-550-80 1989A Dec-20
54838-550-80 1794A Jun-20 54838-550-80 1990A Dec-20
54838-550-80 1795A Jun-20 54838-550-80 1991A Dec-20
54838-550-80 1796A Jun-20 54838-550-80 1998A Jan-21
54838-550-80 1817A Jun-20 54838-550-80 1999A Jan-21
54838-550-80 1818A Jul-20 54838-550-80 2000A Jan-21
54838-550-80 1819A Jul-20 54838-550-80 2019A Jan-21
54838-550-80 1840A Aug-20 54838-550-80 2020A Jan-21
54838-550-80 1840B Aug-20 54838-550-80 2065A Mar-21
54838-550-80 1841A Aug-20 54838-550-80 2066A Mar-21
54838-550-80 1842A Aug-20 54838-550-80 2067A Mar-21
54838-550-80 1863A Aug-20 54838-550-80 2071A Mar-21
54838-550-80 1864A Sep-20 54838-550-80 2072A Mar-21
54838-550-80 1865A Sep-20 54838-550-80 2073A Mar-21
54838-550-80 1899A Oct-20 54838-550-80 2076A Mar-21
54838-550-80 1900A Oct-20 54838-550-80 2077A Mar-21
54838-550-80 1901A Oct-20 54838-550-80 2078A Mar-21
54838-550-80 1910A Oct-20 54838-550-80 2126A May-21
54838-550-80 1911A Oct-20 54838-550-80 2127A May-21
54838-550-80 1912A Oct-20 54838-550-80 2128A May-21
54838-550-80 1918A Oct-20 54838-550-80 2164A Jun-21
54838-550-80 1919A Oct-20 54838-550-80 2165A Jun-21
54838-550-80 1920A Oct-20 54838-550-80 2166A Jun-21
54838-550-80 1925A Oct-20 54838-550-80 2179A Jun-21
54838-550-80 1926A Oct-20 54838-550-80 2180A Jul-21
54838-550-80 1927A Oct-20 54838-550-80 2181A Jul-21
54838-550-80 1977A Dec-20 54838-550-80 2214A Aug-21
54838-550-80 1978A Dec-20 54838-550-80 2215A Aug-21
54838-550-80 1979A Dec-20 54838-550-80 2216A Aug-21


Novitium Pharma Voluntarily Recalled Products:

Description Strength Type Pack Size NDC
Ranitidine Capsules 150mg 150 mg Rx 60 ct bottle 70954-001-20
Ranitidine Capsules 150mg 150 mg Rx 500 ct bottle 70954-001-40
Ranitidine Capsules 300mg 300 mg Rx 30 ct bottle 70954-002-10
Ranitidine Capsules 300mg 300 mg Rx 100 ct bottle 70954-002-40


Amneal Pharmaceuticals, LLC. Voluntarily Recalled Products:

Product Strength NDC Number
Ranitidine Tablets, USP 150 mg 65162-253-06
Ranitidine Tablets, USP 150 mg 65162-253-10
Ranitidine Tablets, USP 150 mg 65162-253-18
Ranitidine Tablets, USP 150 mg 65162-253-50
Ranitidine Tablets, USP 150 mg 65162-253-11
Ranitidine Tablets, USP 300 mg 65162-254-03
Ranitidine Tablets, USP 300 mg 65162-254-10
Ranitidine Tablets, USP 300 mg 65162-254-25
Ranitidine Tablets, USP 300 mg 65162-254-11
Ranitidine Tablets, USP 150 mg 53746-253-05
Ranitidine Tablets, USP 150 mg 53746-253-10
Ranitidine Syrup (Ranitidine Oral Solution, USP) 15 mg/mL; 16 fl. oz. 65162-664-90


Aurobindo Pharma USA, Inc. Voluntarily Recalled Products:

Product Name NDC Exp. Date
Ranitidine Tablets 150mg 55910-092-79 Feb-21
Ranitidine Capsules 150mg 59651-144-60 Jul-20
Jul-20
59651-144-05 Jul-20
Jul-20
Aug-20
Aug-20
59651-144-60 Aug-20
Aug-20
59651-144-05 Sep-20
Sep-20
Sep-20
Oct-20
Nov-20
Nov-20
Nov-20
Nov-20
Nov-20
59651-144-60 May-21
59651-144-05 May-21
May-21
Ranitidine Capsules 300mg 59651-145-30 Jul-20
Jul-20
Jul-20
Aug-20
Aug-20
Aug-20
Sep-20
Sep-20
Sep-20
Oct-20
Jan-21
Jan-21
May-21
Ranitidine Syrup (Ranitidine Oral Solution, USP)  15 mg/mL (75 mg/5 mL) 65862-431-74 May-21
May-21
May-21
May-21