Aurobindo Recalls Metformin Hydrochloride Tablets Due to Foreign Tablet Presence
Aurobindo Pharma is recalling Metformin Hydrochloride 1000 mg tablets because a foreign tablet was found in the bottle.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard involves a foreign tablet of the same active ingredient, which is a minor labeling/packaging error rather than a high-risk contamination.
Plain-English summary
Aurobindo Pharma Ltd. is recalling 7,476 bottles of Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles. The recall is due to the presence of a foreign tablet, specifically Metformin BP 1000mg, found in a bottle of Metformin HCl 1000mg. The affected product is identified by Lot # MTSC17145-A with an expiration date of July 2021.
The product was distributed nationwide within the US. It is a prescription-only medication manufactured for Aurobindo Pharma USA, Inc. and manufactured by Aurobindo Pharma Limited in India.
Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recall details, they should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- Aurobindo Pharma Ltd.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 7,476
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 (2)
- Lot#: MTSC17145-A
- Exp. July 2021
UPCs (3)
- 0365862010018
- 0365862009012
- 0365862008015
Distribution
Distributed nationwide across the United States.
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