Granules Pharmaceuticals Trazodone 50mg Recall: Foreign Tablets Found
Granules Pharmaceuticals recalls 50mg Trazodone 100-count bottles due to foreign tablets/capsules. Rx-only medication manufactured in India, batch 6160008A, expires Dec 2026.
Lower-risk recall
Presence of Foreign Tablets/Capsules
Contact the company
What happened, in plain English
Granules Pharmaceuticals is recalling 50mg Trazodone Hydrochloride 100-count bottles because foreign tablets or capsules were found in the product. This could pose a risk if someone takes the wrong medication. Read more at govinfonow.com/recall/31510-granules-pharmaceuticals-trazodone-50mg-recall-foreign-tablets-found.
Source Summary by GovInfoNow · govinfonow.com/recall/31510-granules-pharmaceuticals-trazodone-50mg-recall-foreign-tablets-found · Updated August 17, 2026 · FDA enforcement record: FDA #D-0305-2026
Cite this page
“Granules Pharmaceuticals Trazodone 50mg Recall: Foreign Tablets Found.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31510-granules-pharmaceuticals-trazodone-50mg-recall-foreign-tablets-found. Based on FDA recall #D-0305-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0305-2026%22&limit=1).
Why it’s dangerous
Foreign tablets or capsules were found in the product. This could mean someone might accidentally take the wrong medication if the foreign items are mistaken for the actual Trazodone tablets.
Who’s affected
People with a prescription for Trazodone 50mg who purchased this specific bottle from the manufacturer. Those who take the medication as directed are most at risk.
How to tell if you have this one
Check for the product name 'Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle' on the label. Look for batch number 6160008A and expiration date 12/31/2026.
- Brand
Granules Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Label
Look for the batch number 6160008A and expiration date 12/31/2026 on the label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 16 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-0305-2026 (January 26, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0305-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.