Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brand
- Sun Pharmaceutical Industries
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- Sun Pharmaceutical Industries
- Product type
- Radionuclide kit or radiopharmaceutical preparation kit
- Model numbers
- Lot AD70995
- UPC codes
- 45567-0655, 45567-0655-1
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 3, 2025
Reported by FDA DRUG
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact SUN PHARMACEUTICAL INDUSTRIES INC or your healthcare provider for guidance. Notification method: Letter
About This Product
Radiopharmaceutical kits like this enable clinicians to prepare Tc-99m Mertiatide for imaging. They are Rx-only and used in medical facilities.
Why This Is Dangerous
An out-of-spec dissolution in a component could compromise product quality and patient safety, though no injuries reported yet.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Immediate stop-use and notification are required to prevent potential compromised imaging agents.
Practical Guidance
How to identify if yours is affected
- Check lot AD70995 and expiry 10/31/2025 on the kit packaging.
- Verify NDC 45567-0655-1 and product name.
- Confirm nationwide distribution status.
Where to find product info
Recall notice on FDA enforcement site and Sun Pharmaceutical communications.
What timeline to expect
Refunds or replacements typically follow standard drug recall timelines (variable by distributor).
If the manufacturer is unresponsive
- Escalate to FDA recall contacts
- File a consumer complaint with CPSC if applicable
- Consult hospital's recall coordinator
How to prevent similar issues
- Implement robust lot-tracking and quarantine processes for radiopharmaceuticals
- Verify dissolution specs in incoming components
- Strengthen supplier qualification and lot release testing
Documentation advice
Keep recall notice, lot AD70995, expiry date, and all correspondence with Sun Pharmaceutical.
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Product Details
Brand: Sun Pharmaceutical Industries. Product: Kit for the Preparation of Technetium Tc 99m Mertiatide. NDC: 45567-0655-1. Lot: AD70995. Expiry: 10/31/2025. Quantity: 1870 kits. Distribution: US Nationwide. Type: Rx-only radiopharmaceutical preparation kit.
Reported Incidents
No specific patient injuries or incidents reported in the available data.
Key Facts
- Nationwide distribution in the U.S.
- OOS dissolution issue for sulphate in Sodium Tartrate Dihydrate
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Safety Guide
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