Dr. Reddy's Recalls Clopidogrel Tablets Due to Dissolution Failure
Dr. Reddy's Laboratories is recalling specific lots of Clopidogrel Bisulfate 300 mg tablets because they failed dissolution specifications during stability testing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The hazard is a quality control failure (dissolution) without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary measures.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 4,404 blister packs of Clopidogrel Bisulfate (Clopidogrel) Tablets, USP, 300 mg. The affected product is distributed in 30-count blister packs (5 x 6 unit-dose) and is available by prescription only. The specific lots involved are T700423 (expiration 08/2019) and T800310 (expiration 03/2020), with NDC 55111-671-31.
The recall was initiated because two additional lots produced Out-of-Specification results for dissolution during the 18th month of stability testing. Dissolution is a critical quality attribute that ensures the drug releases into the body in a consistent manner; failure to meet these specifications may affect the drug's performance.
The product was distributed to four major distributors who then distributed it throughout the United States. Patients and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the distributor or pharmacy for credit. Consumers should consult their healthcare provider regarding alternative treatment options if they are currently using this medication.
The recalled product
- Product
- CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE)
- Brand
- CLOPIDOGREL BISULFATE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Medication
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 #: T700423
- Exp 08/2019
- T800310
- Exp 03/2020
Distribution
Distribution scope not specified by the agency.
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