Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity
Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected NDMA impurity above acceptable intake levels.
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, which corresponds to a 'Severe' rating under the rubric, particularly given the presence of a carcinogenic impurity (NDMA) above acceptable levels.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC is recalling Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg. The recall involves prescription bottles containing 100 tablets, manufactured by Amneal Pharmaceuticals Pvt. Ltd. in India and distributed by Amneal Pharmaceuticals LLC in New Jersey. The product is identified by NDC 65162-179-10.
The recall was initiated because FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level. This is classified as a Current Good Manufacturing Practice (CGMP) deviation. The affected lots are distributed nationwide.
Patients and healthcare providers should check their medication for the specific lot codes listed in the recall notice. If the medication matches the recalled lots, it should not be used. Patients should contact their healthcare provider for guidance on alternative treatment options.
The recalled product
- Product
- METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- 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)
- 0365162178104
- 0365162179101
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Amneal Pharmaceuticals of New York, LLC 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 12 products in this recall →Related recalls
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