Dr. Reddy's Recalls Rivastigmine Tartrate Capsules for Dissolution Failures
Dr. Reddy's Laboratories is recalling Rivastigmine Tartrate capsules because they 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 corresponds to a moderate severity level involving temporary or medically reversible adverse health consequences, such as therapeutic failure due to dissolution issues.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottles. The recall involves 2,952 bottles distributed nationwide. The specific lot number is C501342, with an expiration date of 01/2017.
The recall was initiated because the product failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the drug releases its active ingredient at the appropriate rate in the body. Failure to meet these specifications can result in the medication not working as intended.
Patients and healthcare providers should stop using the affected product and contact their healthcare provider for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- RIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE)
- Brand
- RIVASTIGMINE TARTRATE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 2,952
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 #: C501342
- Exp 01/2017
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · RIVASTIGMINE TARTRATE
- LowDr. Reddy's Recalls Rivastigmine Tartrate Capsules Due to Cross-Contamination
FDA (Drugs) · 2017-04-12
Same manufacturer · Dr. Reddy's Laboratories, Inc.
See all →- ModerateVarenicline tablets recalled after an assay value fell below specification
FDA (Drugs) · 2025-12-17
- Moderate
- HighOmeprazole capsule bottle contained a foreign divalproex sodium tablet
FDA (Drugs) · 2025-07-23
- SevereLevetiracetam Injection Label Mismatch Nationwide Recall
FDA (Drugs) · 2025-04-23
- ModerateFDA Recalls JAVYGTOR Tablets Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2024-12-18
Same hazard · dissolution failure
See all →- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
- ModerateChlorthalidone 25mg tablets failed dissolution specifications in two batches
FDA (Drugs) · 2026-06-24
- ModerateNiacin extended-release tablets failed dissolution testing at 24 hours
FDA (Drugs) · 2026-06-17
- ModerateMinocycline extended-release tablets failed dissolution testing during stability analysis
FDA (Drugs) · 2026-06-17