The Recall Desk
SevereFDA (Drugs)·D-0181-2020·Announced 2019-11-13

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

Dr. Reddy's is recalling Ranitidine Tablets 75 mg because the FDA detected the NDMA impurity in the product.

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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant health risks.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Ranitidine Tablets, USP 75 mg, 60 count bottles (NDC 55111-131-60). The product is an over-the-counter medication distributed to major distributors throughout the United States, who may have further distributed it.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. The recall includes all lots within the expiry date.

Consumers should stop using the recalled product and return it to the place of purchase or contact the manufacturer for further instructions.

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

Same manufacturer · Dr. Reddy's Laboratories, Inc.

See all →

Same hazard · ndma impurity

See all →