The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0185-2020·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 an NDMA impurity was detected. 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant health risks like NDMA impurities are categorized as Severe (Score 4), as they are not Class I but involve serious potential harm.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC. The recall was initiated 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 expiry date. The medication was distributed to major distributors throughout the United States, who may have further distributed the product to retail locations.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatments. The recall is classified as FDA Class II.

The recalled product

Product
Ranitidine Tablets, USP 150 mg, NDC 57896-717 (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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