Startseite/Alle Rückrufe/FDA-D-0775-2026
FDA DrugsClass II

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17.

Veröffentlicht: 2. September 2026Rückruf-ID: D-0775-2026Kategorie: Arzneimittel & MedikamenteLand: Vereinigte Staaten
US
PharmaceuticalFDA DrugsUSUS

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17.

Recalling Firm: ACCORD HEALTHCARE, INC.

🌐
Mitteilung übersetzenTranslate notice text, hazard warnings, and descriptions into any supported language.

Grund für den Rückruf / Gefahr

Subpotent Drug

Produktbeschreibung & Identifikation

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17.

Additional Source Details

FieldValue
CityRaleigh
StateNC
Openfda › Upc › 10316729447157
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Openfda › Spl id415fc774-31a5-124f-e063-6294a90a0e46
Openfda › Brand nameLEVOTHYROXINE SODIUM
Openfda › Spl set ida6233381-3043-4e9a-aaa6-a6b105e5142b
Openfda › Package ndc › 116729-458-15
Openfda › Package ndc › 216729-458-17
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Openfda › Product ndc › 116729-447
Openfda › Product ndc › 216729-458
Openfda › Product ndc › 316729-448
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Openfda › Product ndc › 1016729-455
Openfda › Product ndc › 1116729-456
Openfda › Product ndc › 1216729-457
Openfda › Generic nameLEVOTHYROXINE SODIUM
Openfda › Product typeHUMAN PRESCRIPTION DRUG
Openfda › Substance nameLEVOTHYROXINE SODIUM
Openfda › Manufacturer nameAccord Healthcare Inc.
Openfda › Application numberANDA212399
Openfda › Is original packagertrue
Event id99584
Address 18041 Arco Corporate Dr Ste 200
Address 2N/A
Code infoLot #: D2401927, D2401833, Exp. Date 08/31/2026; D2402551, D2402552, Exp. Date 11/30/2026; D2500220, Exp. Date 12/31/2026; D2500223, Exp. Date 01/31/2027.
Postal code27617-2010
Report date20260902
Product typeDrugs
Product quantityN/A
Reason for recallSubpotent Drug
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260806
Initial firm notificationLetter
Center classification date20260821

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 Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcar...?

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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Übersicht

  • Rückrufendes UnternehmenACCORD HEALTHCARE, INC.
  • StatusOngoing
  • RisikostufeClass II
  • DistributionNationwide within the United States
Recall Hazard Severity
High Alert (Class I)
Offizielle Behördenwarnung

📢 Warnung teilen

Alert family and friends to keep them safe. Copy this quick alert message:

🚨 SAFETY ALERT: ACCORD HEALTHCARE, INC. - Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17.

Check if your household is affected:
https://therecallfile.com/de/recalls/levothyroxine-sodium-tablets-usp-25-mcg-0-025-mg-1000-count-bottles-rx/FDA-D-0775-2026
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Spread the WordLevothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17.

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Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17.

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