Risedronate Sodium Tablets Recalled for Failed Content Uniformity Specifications
Macleods Pharma USA Inc is recalling Risedronate Sodium 5 mg tablets (Lot BRD2001A, expiration 5/2022) due to failed content uniformity specifications. The recall affects 4,872 bottles distributed nationwide.
What this means for you
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: FDA Class III classification with no reported illnesses or injuries. Manufacturing control failure creates theoretical dosing inconsistency but without documented patient harm, this is classified as a precautionary moderate recall per the rubric.
Plain-English summary
Macleods Pharma USA Inc issued a nationwide recall of Risedronate Sodium Tablets, USP, 5 mg (NDC 33342-107-07) manufactured by Macleods Pharmaceuticals Ltd. in Himachal Pradesh, India. The recall affects 4,872 bottles with Lot #BRD2001A, with an expiration date of May 2022.
The manufacturer initiated the recall due to failed content uniformity specifications. Content uniformity testing verifies that the active ingredient is consistently distributed throughout the tablet batch.
The affected product was distributed nationwide in the United States. Patients should not stop taking their medication without consulting their healthcare provider.
Consumers with bottles from the recalled lot should contact their pharmacy or healthcare provider for guidance. The FDA is monitoring the situation as the manufacturer investigates the manufacturing controls that led to the content uniformity failure.
The recalled product
- Product
- RISEDRONATE SODIUM (RISEDRONATE SODIUM)
- Brand
- RISEDRONATE SODIUM
- Manufacturer
- Macleods Pharma Usa Inc
- Hazard
- content-uniformity-failure
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 #: BRD2001A
- Exp 5/2022
Distribution
Distributed nationwide across the United States.
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