Macleods Pharma Recalls Subpotent Pioglitazone and Metformin Tablets
Macleods Pharma USA is recalling two lots of Pioglitazone and Metformin Hydrochloride tablets because they tested below the required potency levels.
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 unlikely to cause adverse health consequences. The hazard is a subpotent drug (lower potency), which is a quality issue rather than a direct safety hazard like contamination or mislabeling of a dangerous substance.
Plain-English summary
Macleods Pharma USA, Inc. is recalling two lots of Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg. The recall involves 4,694 60-count bottles distributed nationwide. The specific lots affected are BPA5903A (expiration 05/2021) and BPA5819A (expiration 11/2020).
The recall was initiated because the tablets failed to meet the required potency standards, resulting in out-of-specification assay results that were below the specified limits. This means the medication may not contain the full amount of active ingredients intended.
Consumers who have these specific lots should stop using the medication and contact their healthcare provider or pharmacist for guidance. The product is a prescription-only medication manufactured for Macleods Pharma USA, Inc. in Plainsboro, NJ, and manufactured by Macleods Pharmaceuticals Ltd. in India.
The recalled product
- Product
- PIOGLITAZONE AND METFORMIN HYDROCHLORIDE (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE)
- Brand
- PIOGLITAZONE AND METFORMIN HYDROCHLORIDE
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Prescription Drug
- Hazard
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 (4)
- Lot# BPA5903A
- EXP 05/2021
- BPA5819A
- EXP 11/2020
UPCs (3)
- 0333342177117
- 0333342177094
- 0333342176448
Distribution
Distributed nationwide across the United States.
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