PhotoDr. Reddy’s Laboratories is recalling of all of its ranitidine medications sold in U.S.

The products are contaminated with N-Nitrosodimethylamine (NDMA), a probable human carcinogen, above levels established by the FDA.

The firm has not received any reports of adverse events.

Ranitidine is available as an over-the-counter (OTC) and prescription drug used to relieve heartburn associated with acid indigestion and sour stomach. The tablets are also used to prevent heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.

The following products with expiration dated September 2019, to March 2022, are being recalled:

DescriptionStrengthTypePackNDC
Ranitidine Capsules 150mg, 60150 mgRx60 ct bottle5511112960
Ranitidine Capsules 150mg, 500150 mgRx500 ct bottle5511112905
Ranitidine Capsules 300mg, 30300 mgRx30 ct bottle5511113030
Ranitidine Capsules 300mg, 100300 mgRx100 ct bottle5511113001
Rantidine Tablets, USP 150mg,190(2x95)Tray (Sam’s Club)150 mgOTC190 ct (2x95) tray150062076
(UPC Code 078742089720)
Ranitidine Tablets, USP 150mg, 95 (Walgreens)150 mgOTC95 ct bottle0363-0010-62
Ranitidine Tablets, USP 150 mg 220 CT Btl (Walmart)150 mgOTC220 ct bottle49035-404-65
Ranitidine Tablets, USP 150mg 50ct Btl (Kroger)150 mgOTC50 ct bottle30142-505-50
Ranitidine Tablets, USP 150mg 24ct Btl (Kroger)150 mgOTC24 ct bottle30142-505-34
Ranitidne Tablets, USP 150mg 65 Ct Btl (Walgreens)150 mgOTC65 ct bottle0363-0010-61
Ranitidine Tablets, USP 150 TAB 65ct BTL CP32 (Walmart)150 mgOTC65 ct bottle49035-404-61
Ranitidine Tablets, USP 150 Tab 200Ct Btl (Walgreens)150 mgOTC200 ct bottle0363-0010-01
Ranitidine Tablets, USP 150mg Tabs Btl, 24 (Walgreens)150 mgOTC24 ct bottle0363-0010-34
Ranitidine Tablets, USP 75 TAB 30ct Bottle NG (CVS)75 mgOTC30 ct bottle69842-871-30
Ranitidine Tablets, USP 75mg Tab 30Ct Btl (Walgreens)75 mgOTC30 ct bottle0363-0131-30
Ranitidine Tablets, USP 75mg Tab 80Ct Btl (Walgreens)75 mgOTC80 ct bottle0363-0131-80
Ranitidine Tablets, USP 75 TAB 80ct Bottle NG (CVS)75 mgOTC80 ct bottle69842-871-80
Ranitidine Tablets, USP 75 TAB 160ct Bottle NG (CVS)75 mgOTC160 ct bottle69842-871-37
Ranitidine Tablets, USP 75mg 30ct Btl (Kroger)75 mgOTC30 ct bottle30142-131-30
Ranitidine Tablets, USP 150 TAB 24ct BTL (CDMA)150 mgOTC24 ct bottle63868-480-24
Ranitidine Tablets, USP 150 Tablet 130ct Bottle NV (Walmart)150 mgOTC130 ct bottle49035-404-13
Ranitidine Tablets, USP 150 TAB 50ct BTL (CDMA)150 mgOTC50 ct bottle63868-480-50
Ranitidine Tablets, USP 75 Tab 60ct Btl (Dr. Reddy’s)75 mgOTC60 ct bottle55111-131-60
Ranitidine Tablets, USP 75 TAB 60ct BTL (CDMA)75 mgOTC60 ct bottle63868-482-60
Ranitidine Tablets, USP 75 TAB 30ct BTL (CDMA)75 mgOTC30 ct bottle63868-482-30
Ranitidine Tablets, USP 150mg Tablets 24ct BTL00 (Dr. Reddy’s)150 mgOTC24 ct bottle55111-404-34
Ranitidine Tablets, USP 150 Tab 95ct Btl (HCA)150 mgOTC95 ct bottle43598-808-62
Ranitidine Tablets, USP 150 Tab 220ct Btl (HCA)150 mgOTC220 ct bottle43598-808-65
Ranitidine Tablets, USP Tab 150mg 40ct Bottle (Target)150 mgOTC40 ct bottle11673-849-40
Ranitidine Tablets, USP 150 Tab 24ct Btl (Thirty Madison)150 mgOTC24 ct bottle71713-203-02
Ranitidine Tablets, USP 150 Tab 95ct Btl (Thirty Madison)150 mgOTC95 ct bottle71713-203-05
Ranitidine Tablets, USP 75mg  (GeriCare)75 mgOTCAll counts57896-715
Ranitidine Tablets, USP 150mg (GeriCare)150 mgOTCAll counts57896-717

The recalled products can be identified by NDC numbers on the product label.

What to do

Patients should contact their healthcare provider if they have any problems that may be related to taking or using the recalled product.

Consumers with questions or who want to report an adverse event may contact the company’s medical information call center at (888) 375-3784 (888-DRL-DRUG) fro 8 a.m. – 8 p.m. (ET) Monday through Friday.

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