Class II U.S. Food and Drug Administration

Granules Pharmaceuticals Inc. Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle recall: Presence of Foreign Tablets/Capsules

Recall published 9 months ago

Presence of Foreign Tablets/Capsules

The hazard: Drug safety concern

This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

What the notice says: Presence of Foreign Tablets/Capsules

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0305-2026
Published
February 11, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Granules Pharmaceuticals Inc.
Product type
Prescription & OTC drugs
Units affected
71424 bottles.
Distribution
Nationwide
Made in
United States
Lot / code info
Batch # 6160008A, Exp Date: 12/31/2026

Products covered by this recall

Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01.

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 6160008A

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 12
  • 31
  • 2026 — 71424 bottles

NDC number

On the carton and again on the bottle or blister label.

  • 70010-231-01

Package size

Match the net weight or the piece count on the front of the pack.

  • 50 mg
  • 100 Count

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Granules Pharmaceuticals Inc. — This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

  1. Check the lot number on your pack against the codes listed above.
  2. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  3. Keep the carton; the lot number is often printed only on the outer pack.
  4. Report side effects you think the product caused to FDA MedWatch.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Granules Pharmaceuticals Inc. — 3701 Concorde Pkwy, Chantilly, VA, 20151-1126

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Granules Pharmaceuticals Inc. prescription & otc drugs recalled?

Presence of Foreign Tablets/Capsules Presence of Foreign Tablets/Capsules

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 6160008A; best-by date 12 or 31. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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