The Recall Desk
SevereFDA (Drugs)·D-0182-2020·Announced 2019-11-13

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

Dr. Reddy's is recalling Ranitidine Tablets because an NDMA impurity was detected. Consumers should stop using the product and return it to the pharmacy.

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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant health risks like NDMA impurities are categorized as Severe.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Ranitidine Tablets, USP 150 mg, 24 count bottles (NDC 55111-404-34). The recall was initiated because the presence of the NDMA impurity was detected in the product.

The affected product was distributed to major distributors throughout the United States, who may have further distributed the product. All lots within the expiry date are included in this recall.

Consumers should stop using the recalled product and return it to the pharmacy or place of purchase for a refund.

The recalled product

Product
RANITIDINE (RANITIDINE)
Brand
RANITIDINE
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — 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 →

Related recalls

Same brand · RANITIDINE

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Same hazard · ndma impurity

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