Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity
Dr. Reddy's Laboratories is recalling Ranitidine Tablets 75 mg because the presence of the NDMA impurity was detected 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 and involves the detection of NDMA, a known carcinogenic impurity, which meets the rubric criteria for a Severe rating.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Ranitidine Tablets 75 mg, available in 30-count and 60-count bottles, due to the presence of the NDMA impurity. The recall covers all lots within the expiration date for the specific NDC codes 63868-482-30 and 63868-482-60.
The product was distributed to major distributors throughout the United States, who may have further distributed the product to retail locations. The recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers who have purchased these specific bottles of Ranitidine Tablets should stop using the product and contact their healthcare provider or pharmacist for guidance on alternatives or refunds.
The recalled product
- Product
- Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- 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.
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