Dr. 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:
| 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 (UPC Code 078742089720) |
| 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 |
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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