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FDA DrugsClass III

traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10

Published: January 7, 2026Recall ID: D-0247-2026Category: Drugs & MedicineCountry: United States
US
PharmaceuticalFDA DrugsUSUS

traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10

Recalling Firm: Zydus Pharmaceuticals (USA) Inc

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Translate NoticeTranslate notice text, hazard warnings, and descriptions into any supported language.

Reason for Recall / Hazard

Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.

Product Description & Identification

traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10

Additional Source Details

FieldValue
CityPennington
StateNJ
Openfda › Upc0368382808011
Openfda › Unii6E8ZO8LRNM
Openfda › RouteORAL
Openfda › Rxcui › 1856364
Openfda › Rxcui › 2856369
Openfda › Rxcui › 3856373
Openfda › Rxcui › 4856377
Openfda › Spl id24cb2e4c-a9ba-4283-8396-343f6aa03121
Openfda › Brand nameTRAZODONE HYDROCHLORIDE
Openfda › Spl set id704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9
Openfda › Package ndc › 168382-805-01
Openfda › Package ndc › 268382-805-30
Openfda › Package ndc › 368382-805-77
Openfda › Package ndc › 468382-805-05
Openfda › Package ndc › 568382-805-10
Openfda › Package ndc › 668382-805-06
Openfda › Package ndc › 768382-805-16
Openfda › Package ndc › 868382-806-06
Openfda › Package ndc › 968382-806-16
Openfda › Package ndc › 1068382-806-01
Openfda › Package ndc › 1168382-806-05
Openfda › Package ndc › 1268382-806-10
Openfda › Package ndc › 1368382-806-30
Openfda › Package ndc › 1468382-806-77
Openfda › Package ndc › 1568382-807-06
Openfda › Package ndc › 1668382-807-16
Openfda › Package ndc › 1768382-807-01
Openfda › Package ndc › 1868382-807-05
Openfda › Package ndc › 1968382-807-10
Openfda › Package ndc › 2068382-807-30
Openfda › Package ndc › 2168382-807-77
Openfda › Package ndc › 2268382-808-06
Openfda › Package ndc › 2368382-808-16
Openfda › Package ndc › 2468382-808-01
Openfda › Package ndc › 2568382-808-05
Openfda › Package ndc › 2668382-808-10
Openfda › Package ndc › 2768382-808-30
Openfda › Package ndc › 2868382-808-77
Openfda › Package ndc › 2968382-609-01
Openfda › Package ndc › 3068382-609-05
Openfda › Package ndc › 3168382-609-10
Openfda › Package ndc › 3268382-610-01
Openfda › Package ndc › 3368382-610-05
Openfda › Package ndc › 3468382-610-10
Openfda › Product ndc › 168382-609
Openfda › Product ndc › 268382-805
Openfda › Product ndc › 368382-806
Openfda › Product ndc › 468382-807
Openfda › Product ndc › 568382-808
Openfda › Product ndc › 668382-610
Openfda › Generic nameTRAZODONE HYDROCHLORIDE
Openfda › Product typeHUMAN PRESCRIPTION DRUG
Openfda › Substance nameTRAZODONE HYDROCHLORIDE
Openfda › Manufacturer nameZydus Pharmaceuticals USA Inc.
Openfda › Application numberANDA205253
Openfda › Is original packagertrue
Event id98184
Address 173 Route 31 N
Address 2N/A
Code infoLot # EA00237A, Exp Date: 04/30/2027
Postal code08534-3601
Report date20260107
Product typeDrugs
Product quantity2,136 1000-count bottles
Reason for recallFailed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20251219
Initial firm notificationLetter
Center classification date20251231

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India,...?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Overview

  • Recalling FirmZydus Pharmaceuticals (USA) Inc
  • StatusOngoing
  • Risk LevelClass III
  • DistributionNationwide in the USA
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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🚨 SAFETY ALERT: Zydus Pharmaceuticals (USA) Inc - traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10

Check if your household is affected:
https://therecallfile.com/recalls/trazodone-hydrochloride-tablets-usp-100mg-1-000-tablets-rx-only-manufa/FDA-D-0247-2026
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Spread the WordtraZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10

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