The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0178-2020·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 NDMA impurity. The product was distributed to major distributors throughout the United States.

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 source identifies the recall as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the presence of a known carcinogenic impurity (NDMA) which poses a significant health risk.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Ranitidine Tablets, USP 75 mg (NDC 57896-715), sold under the GeriCare brand. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product.

The affected product includes all lots within the expiration date. The medication was distributed to major distributors throughout the United States, who may have further distributed the product to retail locations.

Consumers should stop using the recalled product and return it to the place of purchase for a refund. This recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.
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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