Ajanta Pharma Recalls Ranolazine Tablets for Dissolution Failure
Ajanta Pharma USA Inc. is recalling Ranolazine Extended-Release Tablets, 1000 mg, because the product failed to meet dissolution specifications.
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: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The specific defect is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or structural hazard.
Plain-English summary
Ajanta Pharma USA Inc. is recalling Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottles. The recall is due to the product failing to meet dissolution specifications, meaning the tablets did not dissolve as required by the standard.
The affected product is marketed by Ajanta Pharma USA Inc. in Bridgewater, NJ. The specific lot number is DJ25134, with an expiration date of 11/30/2028. The product is distributed nationwide in the US.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- RANOLAZINE (RANOLAZINE)
- Brand
- RANOLAZINE
- Manufacturer
- Ajanta 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 (2)
- Lot: DJ25134
- Exp 11/30/2028
UPCs (2)
- 0327241125027
- 0327241126024
Distribution
Distributed nationwide across the United States.
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