Dr. Reddy's Recalls Ranitidine Capsules Due to NDMA Impurity
Dr. Reddy's is recalling Ranitidine Hydrochloride capsules because of CGMP deviations and the presence of NDMA impurity.
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 and involves the detection of NDMA, a known carcinogenic impurity, which aligns with the rubric criteria for Severe severity involving significant health risks.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Ranitidine Hydrochloride capsules, USP 300 mg. The affected products are available in 30-count bottles (NDC 55111-130-30) and 100-count bottles (NDC 55111-130-01). The recall covers all lots within the expiration date.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations and the detection of the NDMA impurity in the product. The FDA has classified this recall as Class II.
The product was distributed to major distributors throughout the United States, who may have further distributed it. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on alternatives.
The recalled product
- Product
- RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE)
- Brand
- RANITIDINE HYDROCHLORIDE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
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
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