Amneal Recalls Ranitidine Tablets Due to NDMA Impurity
Amneal Pharmaceuticals is recalling Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).
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 NDMA, a known carcinogenic impurity, which aligns with the rubric criterion for 'Severe' severity involving significant health risks or agency classifications requiring high vigilance.
Plain-English summary
Amneal Pharmaceuticals, Inc. is recalling Ranitidine Tablets, USP 150 mg, in 60-, 100-, 180-, 500-, and 1000-count bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the presence of the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API).
The affected product was distributed throughout the United States. The recall covers multiple lot numbers manufactured between November 2019 and March 2021.
Consumers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatments. The FDA has classified this recall as Class II, indicating a reasonable probability that adverse health consequences may be temporary or medically reversible.
The recalled product
- Product
- Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).
- Manufacturer
- Amneal Pharmaceuticals, Inc.
- Category
- Drug — Tablets
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Amneal Pharmaceuticals, 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 5 products in this recall →Related recalls
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