Dr. Reddy's Recalls Ranitidine Capsules Due to NDMA Impurity
Dr. Reddy's is recalling Ranitidine Hydrochloride capsules because of the presence of the NDMA impurity.
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 the presence of the NDMA impurity in a prescription drug represents a significant health risk, meeting the criteria for a Severe rating.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Ranitidine Hydrochloride capsules, 150 mg, in 60-count and 500-count bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product.
The affected products are identified by NDC 55111-129-60 and NDC 55111-129-05. The source text indicates that all lots within the expiry date are included in this recall. The product was distributed to major distributors throughout the United States, who may have further distributed the product to pharmacies and other healthcare providers.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on alternatives or returns.
The recalled product
- Product
- RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE)
- Brand
- RANITIDINE HYDROCHLORIDE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
- 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 HYDROCHLORIDE
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