Dr. Reddy's Recalls Divalproex Sodium Tablets for Dissolution Failure
Dr. Reddy's is recalling 10,656 bottles of Divalproex Sodium Extended-release Tablets because they failed to meet dissolution specifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without explicit reports of hospitalization or serious injury are typically scored as High (3), representing a risk of harm where injury has not yet been reported.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 10,656 bottles of Divalproex Sodium Extended-release Tablets, USP 250 mg. The affected product is a prescription-only medication manufactured in India and distributed nationwide in the United States. The specific lot number is C802676, with an expiration date of 03/20.
The recall was initiated because the product failed to meet dissolution specifications, specifically showing out-of-specification results for high dissolution. This means the tablets may not release the medication into the body as intended.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- DIVALPROEX SODIUM (DIVALPROEX SODIUM)
- Brand
- DIVALPROEX SODIUM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 10,656
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 #: C802676
- Exp 03/20
Distribution
Distributed nationwide across the United States.
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