The Recall Desk
SevereFDA (Drugs)·D-0169-2020·Announced 2019-11-13

Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because of the presence of NDMA impurity. The product was distributed to major distributors throughout the United States.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score (4) according to the rubric, as it involves a potential health risk that may cause temporary or medically reversible harm.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076, UPC Code 078742089720. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product.

The affected product was distributed to major distributors throughout the United States, who may have further distributed it. The recall includes all lots within the expiry date. No specific lot numbers or distribution dates are provided in the source text.

Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance. The source text does not specify a particular action for consumers beyond the standard recall notification.

The recalled product

Product
Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription/OTC Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Batch Numbers: All lots within expiry.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 18 recalled by Dr. Reddy's Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 18 products in this recall →

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