Trazodone Hydrochloride — Class II drug recall D-0305-2026
Ongoing recall by Granules Pharmaceuticals Inc., reported 2026-02-11, distributed nationwide. Presence of Foreign Tablets/Capsules
| Recall number | D-0305-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Granules Pharmaceuticals Inc., Chantilly, VA, United States |
| Recall initiated | 2026-01-26 |
| Classified | 2026-02-11 |
| Reported by FDA | 2026-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 71,424 bottles |
| NDC | 70010-0231, 70010-0231-01, 70010-0231-03, 70010-0231-05, 70010-0231-10, 70010-0232, 70010-0232-01, 70010-0232-03, 70010-0232-05, 70010-0232-10, 70010-0233, 70010-0233-01, 70010-0233-03, 70010-0233-05, 70010-0234, 70010-0234-01, 70010-0234-03, 70010-0234-05 |
| Lot numbers | 6160008A |
| Expiration dates | 2026-12-31 |
Product
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.
Reason for recall
Presence of Foreign Tablets/Capsules
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0305-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.