Macleods Pharma Recalls Candesartan Tablets Due to Impurity Failures
Macleods Pharma USA is recalling Candesartan Cilexetil tablets because they failed impurity and degradation specifications.
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 a low probability of adverse health consequences. The hazard involves failed impurity specifications without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Macleods Pharma USA, Inc. is recalling Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles. The recall involves 8,015 packs of the prescription medication, which was distributed nationwide within the United States.
The recall was initiated because the product failed impurities and degradation specifications. The affected lots include ECD5908C (Exp 7/2021) and ECD5909A, ECD5910A, ECD5911A, and ECD5912A (Exp. 09/2021). The medication is manufactured by Macleods Pharmaceuticals Ltd. in India for Macleods Pharma USA, Inc.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- CANDESARTAN (CANDESARTAN)
- Brand
- CANDESARTAN
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 8,015
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 (7)
- Lots # : ECD5908C
- Exp 7/2021
- ECD5909A
- ECD5910A
- ECD5911A
- ECD5912A
- Exp. 09/2021.
UPCs (12)
- 0333342117106
- 0333342116109
- 0333342114105
- 0333342114075
- 0333342116079
- 0333342117076
- 0333342115072
- 0333342114129
- 0333342115102
- 0333342117120
- 0333342115126
- 0333342116123
Distribution
Distributed nationwide across the United States.
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