Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity
Amneal Pharmaceuticals is recalling 192 bottles of Metformin Hydrochloride Extended-Release Tablets, 500 mg, due to N-Nitrosodimethylamine (NDMA) impurity levels above acceptable intake limits.
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. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant chemical impurities like NDMA that exceed acceptable intake levels.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC is recalling 192 bottles of Amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles (NDC 53746-0178-01). The product was distributed nationwide.
The recall was initiated because FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level. This is a Class II recall, indicating a situation in which there is a reasonable probability that the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Patients and healthcare providers should check their inventory for the specific lot codes listed in the recall notice. If the product is found, it should be returned to the pharmacy or distributor for replacement or refund. No specific consumer instructions beyond standard recall procedures are provided in the source text.
The recalled product
- Product
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Category
- Drug — Prescription Medication
- Affected units
- 192
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)
- HA07419A 1/31/2021 HB00119A 1/31/2021 HB00219A 1/31/2021 HB00319A 1/31/2021
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.
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