The Recall Desk
SevereFDA (Drugs)·D-0173-2020·Announced 2019-11-13

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

Dr. Reddy's Laboratories is recalling CVS brand Ranitidine Tablets 75 mg because of the presence of NDMA impurity.

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. According to the rubric, FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe. While no specific injuries are reported in the text, the presence of NDMA (a probable human carcinogen) in a drug product typically warrants a high severity rating, and the rubric dictates that FDA Class I/USDA Class I are never below 4, implying Class II with significant hazards like NDMA falls into the Severe category (4) rather than High (3) which is reserved for theoretical risks or specific pathogens without reported illness.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling CVS brand Ranitidine Tablets, USP 75 mg. The recall covers 30-count, 80-count, and 160-count bottles with NDC codes 69842-871-30, 69842-871-80, and 69842-871-37, respectively. The product is an over-the-counter medication.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. The source text does not specify which lot numbers are affected, stating only "All lots within expiry."

The product was distributed to major distributors throughout the United States, who may have further distributed the product. Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
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
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Over-the-Counter 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 →

Related recalls

Same manufacturer · Dr. Reddy's Laboratories, Inc.

See all →

Same hazard · ndma impurity

See all →