Legacy Pharmaceutical Recalls Metformin Tablets Due to Foreign Imprint
Legacy Pharmaceutical Packaging LLC is recalling 111,948 bottles of Metformin Hydrochloride 1000 mg tablets because tablets with different imprints were found in the bottles.
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 is defined as unlikely to cause adverse health consequences. The hazard involves a labeling/identity discrepancy (different imprint) rather than a confirmed toxic contamination or immediate physical injury risk, fitting the Moderate category for minor labeling or packaging errors.
Plain-English summary
Legacy Pharmaceutical Packaging LLC is recalling 111,948 bottles of Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles. The product is prescription-only and was distributed by Wal-Mart to distribution centers in Georgia and Arkansas. The specific lot number is 201626 with an expiration date of 08/2022.
The recall was initiated due to the presence of foreign tablets or capsules. Specifically, Metformin 1000 mg tablets with a different imprint than expected were found inside the bottles. This discrepancy indicates a potential mix-up during the packaging process.
Consumers who have purchased this specific lot of Metformin Hydrochloride Tablets should stop using the medication and contact their healthcare provider or pharmacist for guidance. The product was manufactured for Heritage Pharmaceuticals Inc. and packaged by Legacy Pharmaceutical Packaging LLC.
The recalled product
- Product
- Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, Distributed by: Wal-Mart, Bentonville, AR 72716. NDC…
- Manufacturer
- Legacy Pharmaceutical Packaging LLC
- Category
- Drug — Prescription Medication
- Affected units
- 111,948
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 #: 201626
- Exp. Date 08/2022
Distribution
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