The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0171-2020·Announced 2019-11-13

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

Dr. Reddy's Laboratories is recalling Walmart-branded Ranitidine Tablets 150 mg because of the presence of the NDMA impurity.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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, particularly given the presence of a known impurity (NDMA) in a pharmaceutical product.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling specific bottles of Ranitidine Tablets, USP 150 mg, sold as a Walmart over-the-counter product. The recall affects 65-count, 130-count, and 220-count bottles with NDC codes 49035-404-61, 49035-404-13, and 49035-404-65, respectively. The product was distributed to major distributors throughout the United States, who may have further distributed it.

The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. The source text indicates that all lots within the expiry date are affected.

Consumers who have purchased these specific bottles of Ranitidine Tablets should stop using them and contact their pharmacist or Dr. Reddy's Laboratories for further instructions on how to return the product or obtain a refund.

The recalled product

Product
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
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 →

Similar recalls