The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0183-2020·Announced 2019-11-13

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

Dr. Reddy's Laboratories is recalling Ranitidine Tablets 75 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 and involves the presence of the NDMA impurity, a significant safety concern that meets the criteria for a Severe rating.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Ranitidine Tablets, USP 75 mg, sold in 30-count and 80-count bottles under the Walgreens brand. The recall is due to the presence of the NDMA impurity detected in the product.

The affected products include NDC 0363-0131-30 (30-count bottles) and NDC 0363-0131-80 (80-count bottles). The recall covers all lots within the expiration date. 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 return it to the place of purchase for a refund. This recall is classified as Class II by the FDA.

The recalled product

Product
Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) 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 →

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