Ranitidine 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

FDA recall notice · announced November 13, 2019 · Dr. Reddy's Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Notes

Distribution: Product was distributed to major distributors throughout the United States who may have further distributed the product.
Lot/code information: Batch Numbers: All lots within expiry.
Quantity: N/A
Status: Completed
Products in this recall event:
- Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC (D-0175-2020)
- Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC. (D-0179-2020)
- Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger) (D-0174-2020)
- Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC. (D-0178-2020)
- Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC (D-0184-2020)
- Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC (D-0183-2020)
- Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC (D-0185-2020)
- Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count bottles (NDC 30142-505-50) (Kroger) OTC (D-0172-2020)
- Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720 (D-0169-2020)
- Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC. (D-0176-2020)
- Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05) (D-0168-2020)
- Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC) (D-0182-2020)
- Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC) (D-0181-2020)
- Ranitidine 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) (Wa (D-0170-2020)
- Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01) (D-0180-2020)
- Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison) OTC. (D-0177-2020)
- Ranitidine 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 (D-0173-2020)
- Ranitidine 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 (D-0171-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.