Teva Recalls Risedronate Sodium Tablets Due to Dissolution Failures
Teva Pharmaceuticals is recalling Risedronate Sodium Delayed-release Tablets because stability testing revealed low out-of-specification dissolution results.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which indicates the product is not likely to cause adverse health consequences. The hazard is a quality control issue (dissolution) rather than a direct safety threat like contamination or mislabeling of a dangerous substance.
Plain-English summary
Teva Pharmaceuticals USA is recalling Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week. The recall involves 25,916 cartons of the medication, identified by Lot # 34025762A with an expiration date of 06/17. The product is distributed nationwide in the United States and Puerto Rico.
The recall was initiated because stability testing found low out-of-specification dissolution results. This means the tablets may not dissolve properly in the body, which could affect how the medication works.
Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 25,916
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 # 34025762A
- Exp 06/17
Distribution
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