Aurobindo Pantoprazole Tablets Recall: Foreign Tablets Found
Aurobindo Pharma USA recalls Pantoprazole Sodium 40mg tablets due to foreign Montelukast Sodium tablets found in some bottles. No immediate action needed but check for foreign tablets.
Lower-risk recall
Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.
Contact the company
What happened, in plain English
Aurobindo Pharma USA is recalling Pantoprazole Sodium Delayed-Release Tablets (40mg) because foreign Montelukast Sodium tablets were found in some bottles. This could cause confusion or incorrect medication use if the foreign tablets are taken. Read more at govinfonow.com/recall/42499-aurobindo-pantoprazole-tablets-recall-foreign-tablets-found.
Source Summary by GovInfoNow · govinfonow.com/recall/42499-aurobindo-pantoprazole-tablets-recall-foreign-tablets-found · Updated October 9, 2026 · FDA enforcement record: FDA #D-1499-2016
Cite this page
“Aurobindo Pantoprazole Tablets Recall: Foreign Tablets Found.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42499-aurobindo-pantoprazole-tablets-recall-foreign-tablets-found. Based on FDA recall #D-1499-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1499-2016%22&limit=1).
Why it’s dangerous
The product contains foreign Montelukast Sodium tablets that could be mistaken for the intended medication. This might lead to incorrect dosing or unintended medication intake if the foreign tablets are taken.
Who’s affected
Prescription patients who received the recalled Pantoprazole tablets from Aurobindo Pharma USA. Those who have the foreign tablets may be at risk of taking the wrong medication.
How to tell if you have this one
Check for the product name 'Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle' with NDC 65862-0560-90. The recall applies to bottles manufactured for Aurobindo Pharma USA, Inc.
- Brand
Aurobindo- Category
Drug
What to do — step by step
Check for Foreign Tablets
Inspect the bottle for any foreign Montelukast Sodium tablets that may be present.
Where it went and when
Where it was distributed
Distributed in California.
FDA distribution: “CA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1499-2016 (August 3, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1499-2016 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.