Aurobindo Recalls Pantoprazole Tablets Due to Foreign Tablet Presence
Aurobindo Pharma USA is recalling specific bottles of Pantoprazole Sodium Delayed-Release Tablets because a foreign tablet was found inside the container.
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 3/5 (High).
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 involves a risk-of-harm product (foreign object in medication) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Aurobindo Pharma USA, Inc. is recalling 23,016 bottles of Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg. The affected product is identified by NDC 65862-0560-90, lot code PSSB16011-A, and an expiration date of 01/18. The recall was initiated after the firm received a market complaint reporting the presence of one foreign tablet, identified as Montelukast Sodium Chewable Tab 4mg, inside a bottle of the recalled product.
The affected product was distributed in California. Consumers who have this specific product should check their bottles for the matching lot code and expiration date. If the product matches the description, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC…
- Manufacturer
- Aurobindo Pharma USA Inc
- Category
- Drug — Tablets
- Hazard
- Affected units
- 23,016
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)
- PSSB16011-A
- Exp 01/18
Distribution
Distributed in 1 state:
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