Quick Facts at a Glance
- Recall Date
- January 26, 2026
- Hazard Level
- HIGH
- Brands
- TRAZODONE HYDROCHLORIDE, Granules Pharmaceuticals Inc.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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
- TRAZODONE HYDROCHLORIDE, Granules Pharmaceuticals Inc.
- Product type
- Trazodone Hydrochloride
- Model numbers
- Batch # 6160008A, Exp Date: 12/31/2026
- UPC codes
- 70010-231, 70010-232, 70010-233, 70010-234, 70010-231-03, 70010-231-01, 70010-231-05, 70010-231-10 +6 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 26, 2026
Reported by FDA DRUG
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Presence of Foreign Tablets/Capsules
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Granules Pharmaceuticals Inc. or your healthcare provider for guidance. Notification method: N/A
About This Product
Trazodone Hydrochloride is an antidepressant used primarily to treat depression and anxiety disorders. Consumers typically buy it for its sedative effects to help with sleep and mood regulation.
Why This Is Dangerous
The contamination with foreign tablets or capsules poses significant health risks, as these unidentified substances may cause adverse effects or interact negatively with existing medications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers face potential health risks from this recall, requiring immediate action to avoid possible complications.
Practical Guidance
How to identify if yours is affected
- Check the batch number on the bottle.
- Verify if it matches Batch # 6160008A.
- Look for the expiration date, which should be 12/31/2026.
Where to find product info
The batch number and expiration date can typically be found on the label or bottom of the bottle.
What timeline to expect
Realistically, expect 4-6 weeks for refund processing after returning the product.
If the manufacturer is unresponsive
- Document all communications with the company.
- Contact your healthcare provider for further assistance.
- Report to the FDA if the company does not respond.
How to prevent similar issues
- Always check for recalls before purchasing medications.
- Look for signs of damage or tampering on packaging.
- Consult a pharmacist about any concerns with medication quality.
Documentation advice
Keep a record of your purchase, including receipts and communication regarding the recall.
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Product Details
The recall affects Trazodone Hydrochloride, USP, 50 mg, packaged in 100-count bottles. The affected batch number is 6160008A, with an expiration date of December 31, 2026. The product was distributed nationwide in the United States.
Key Facts
- Batch number 6160008A
- Presence of foreign tablets/capsules
- Stop using immediately
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Safety Guide
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