Amneal Recalls Ranitidine Tablets Due to NDMA Impurity
Amneal Pharmaceuticals is recalling Ranitidine 300 mg tablets 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 source text identifies the presence of NDMA, a known carcinogenic impurity, in a prescription drug. Per the rubric, FDA Class II recalls involving significant health risks or structural defects are classified as Severe (4).
Plain-English summary
Amneal Pharmaceuticals, Inc. is recalling Ranitidine Tablets, USP 300 mg, 250-count bottles (NDC 53746-254-02). The recall was initiated because the active pharmaceutical ingredient (API) was found to contain the impurity N-nitrosodimethylamine (NDMA), which constitutes a Current Good Manufacturing Practice (CGMP) deviation.
The affected product was distributed throughout the United States. Specific lot numbers and expiration dates are listed in the recall documentation, including batches from February 2020 through January 2021.
Consumers should stop using the recalled product and consult their healthcare provider for alternative treatment options. The FDA classifies this recall as Class II, indicating a reasonable probability that temporary or medically reversible adverse health consequences may occur.
The recalled product
- Product
- RANITIDINE (RANITIDINE)
- Brand
- RANITIDINE
- Manufacturer
- Amneal Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (2)
- 0353746253019
- 0353746254016
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
Same brand · RANITIDINE
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FDA (Drugs) · 2020-01-08
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FDA (Drugs) · 2019-12-18
- SevereDr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity
FDA (Drugs) · 2019-11-13
- SevereDr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity
FDA (Drugs) · 2019-11-13
Same manufacturer · Amneal Pharmaceuticals, Inc.
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FDA (Drugs) · 2019-12-18
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- ModerateAmneal Recalls Benazepril HCl Tablets Due to Foreign Tablet Presence
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Same hazard · ndma impurity
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- SevereDenton Pharma Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity
FDA (Drugs) · 2020-11-11
- SevereDirect Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity
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