Ranitidine Tablets Recalled Due to NDMA Impurity
Granules India Limited is recalling Ranitidine tablets because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).
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, which corresponds to a Severe rating under the rubric, particularly given the presence of a known carcinogenic impurity (NDMA) in the active ingredient.
Plain-English summary
Granules India Limited is recalling Ranitidine tablets, USP 150mg, 10,000-count bags. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where the impurity N-nitrosodimethylamine (NDMA) was found in the active pharmaceutical ingredient (API).
The affected product is identified by NDC 62207-773-32 and includes specific lot codes ranging from 7730001A to 7730012A. The total quantity involved is 23,090,000 tablets. The product was distributed in Oregon, New York, and New Jersey.
Consumers should check their medication for the specific NDC and lot codes listed in the recall notice. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- RANITIDINE (RANITIDINE)
- Brand
- RANITIDINE
- Manufacturer
- Granules India Limited
- Category
- Drug — Oral Solid Dosage
- Affected units
- 23,090,000
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 (11)
- 7730001A
- 7730002A
- 7730003A
- 7730004A
- 7730005A
- 7730006A
- 7730007A
- 7730008A
- 7730009A
- 7730010A
- 7730011A and 7730012A
Distribution
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