Dr. Reddy's Recalls Divalproex Sodium Tablets Due to Humidity Exposure
Dr. Reddy's Laboratories is recalling Divalproex Sodium Extended-Release Tablets because they were exposed to high humidity during packaging.
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 is a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a cGMP deviation (humidity exposure) without reported illnesses, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Divalproex Sodium Extended-Release Tablets, USP, 250 mg. The recall involves 33,958 bottles in 100-count and 500-count sizes. The product is prescription-only and was manufactured by Dr. Reddy's Laboratories Limited in India.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. Specifically, the product was exposed to relative humidity levels above 50% during packaging operations. This exposure may affect the quality of the medication.
The affected lots are C802629 (Exp. 03/2020), C805680 (Exp. 07/2020), C808821 (Exp. 10/2020), and C806561 (Exp. 10/2020). The product was distributed to major distributors and retailers who may have further distributed it throughout the United States. Consumers should check their medication for these lot numbers and expiration dates. If the product matches the recalled items, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Anticonvulsant
- Affected units
- 33,958
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)
- Lot #: a) C802629
- Exp. 03/2020
- C805680
- Exp. 07/2020
- C808821
- Exp. 10/2020
- b) C806561
Distribution
Distribution scope not specified by the agency.
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