Amneal Recalls Rabeprazole Sodium Tablets for Failed Dissolution Specifications
Amneal Pharmaceuticals is recalling Rabeprazole Sodium Delayed Release Tablets, 20 mg, because the product failed to meet dissolution specifications.
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Amneal Pharmaceuticals LLC is recalling Rabeprazole Sodium Delayed Release Tablets, 20 mg, in 30-count and 90-count bottles. The recall was initiated because the product failed to meet dissolution specifications.
The affected product is prescription-only and was manufactured by Amneal Pharmaceuticals Pvt. Ltd. in Ahmedabad, India, and distributed by Amneal Pharmaceuticals in Bridgewater, New Jersey. The recall covers 105,215 bottles distributed nationwide within the United States and Puerto Rico.
Consumers should stop using the recalled medication and contact their healthcare provider or pharmacist for a replacement or further instructions.
The recalled product
- Product
- Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807
- Manufacturer
- Amneal Pharmaceuticals LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 105,215
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 (10)
- Lot #: a) AR151324
- AR151322
- AR151325
- Exp. 9/2017
- AR160730A
- AR160731A
- AR160732A
- Exp. 05/2018. b) AR151324
- AR160730B
- 5/2018.
Distribution
Distributed nationwide across the United States.
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