Quick Facts at a Glance
- Recall Date
- March 19, 2026
- Hazard Level
- HIGH
- Brands
- TRAMADOL HYDROCHLORIDE, Amneal Pharmaceuticals NY LLC
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- TRAMADOL HYDROCHLORIDE, Amneal Pharmaceuticals NY LLC
- Product type
- Tramadol Hydrochloride Tablets 50 mg
- Model numbers
- AM230987, AR232387, Exp. Date 05/2026, Exp. Date 12/2026, 60219-2348-5
- UPC codes
- 60219-2348, 60219-2348-4, 60219-2348-1, 60219-2348-5, 60219-2348-7
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 19, 2026
Reported by FDA DRUG
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Amneal Pharmaceuticals, LLC or your healthcare provider for guidance
About This Product
Tramadol hydrochloride tablets are prescription analgesics used to treat moderate to moderately severe pain. They require a doctor’s prescription and are dispensed by pharmacies. This recall involves a large batch distributed nationwide.
Why This Is Dangerous
The impurity NDSRI can pose health risks if ingested. The issue was detected during long-term stability testing at controlled storage conditions.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers exposed to the impurity could experience adverse effects. The recall presents an urgent safety action for patients currently taking the affected product.
Practical Guidance
How to identify if yours is affected
- Verify NDC 60219-2348-5 on the package.
- Check Lot AM230987 and Exp dates 05/2026 or 12/2026.
- Look for AR232387 as applicable.
- Confirm distributor is Amneal Pharmaceuticals LLC, Glasgow, KY.
Where to find product info
FDA recall page and the Amneal recall notice through the FDA enforcement database.
What timeline to expect
Refund or replacement timelines are typically 4-6 weeks once the distributor processes the recall.
If the manufacturer is unresponsive
- Document all correspondence with the supplier
- File a complaint with FDA MedWatch if the company is slow to respond
- Consult your pharmacist or doctor for guidance on safe alternatives.
How to prevent similar issues
- Follow recall notices for prescription medications
- Verify drug recalls before filling Rx refills
- Ask clinicians and pharmacists to confirm product lot numbers
- Check NDSRI-related safety alerts for opioids
Documentation advice
Keep packaging, lot numbers, expiry dates, receipts, and all recall communications for records.
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Product Details
Bottle count: 500 per bottle. Quantity recalled: 29,542 bottles. NDC: 60219-2348-5. Lot numbers: AM230987. Expiration dates: 05/2026 and 12/2026. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India. Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141. Sold Rx only. Distribution: Nationwide in the USA.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 29,542 bottles recalled nationwide
- NDSRI impurity out of specification at 24-month stability
- Manufactured in India; Distributed by Amneal LLC in Kentucky
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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