Home/Recalls/FDA-D-0776-2026
FDA DrugsClass II

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.

Published: September 2, 2026Recall ID: D-0776-2026Category: drugsCountry: US
US
PharmaceuticalFDA DrugsUSUS

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.

Recalling Firm: ACCORD HEALTHCARE, INC.

Reason for Recall / Hazard

Subpotent Drug

Product Description & Identification

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.

Additional Source Details

FieldValue
CityRaleigh
StateNC
Openfda › Upc › 10316729447157
Openfda › Upc › 20316729449151
Openfda › Upc › 30316729452151
Openfda › Upc › 40316729454155
Openfda › Upc › 50316729453158
Openfda › Upc › 60316729448154
Openfda › Upc › 70316729451154
Openfda › Upc › 80316729457156
Openfda › Upc › 90316729450157
Openfda › Upc › 100316729456159
Openfda › Upc › 110316729458153
Openfda › Upc › 120316729455152
Openfda › Unii9J765S329G
Openfda › RouteORAL
Openfda › Rxcui › 1892246
Openfda › Rxcui › 2892251
Openfda › Rxcui › 3892255
Openfda › Rxcui › 4966220
Openfda › Rxcui › 5966221
Openfda › Rxcui › 6966222
Openfda › Rxcui › 7966224
Openfda › Rxcui › 8966225
Openfda › Rxcui › 9966248
Openfda › Rxcui › 10966249
Openfda › Rxcui › 11966253
Openfda › Rxcui › 12966270
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
Openfda › Package ndc › 316729-447-15
Openfda › Package ndc › 416729-447-17
Openfda › Package ndc › 516729-448-15
Openfda › Package ndc › 616729-448-17
Openfda › Package ndc › 716729-449-15
Openfda › Package ndc › 816729-449-17
Openfda › Package ndc › 916729-451-15
Openfda › Package ndc › 1016729-451-17
Openfda › Package ndc › 1116729-450-15
Openfda › Package ndc › 1216729-450-17
Openfda › Package ndc › 1316729-452-15
Openfda › Package ndc › 1416729-452-17
Openfda › Package ndc › 1516729-453-15
Openfda › Package ndc › 1616729-453-17
Openfda › Package ndc › 1716729-454-15
Openfda › Package ndc › 1816729-454-17
Openfda › Package ndc › 1916729-455-15
Openfda › Package ndc › 2016729-455-17
Openfda › Package ndc › 2116729-456-15
Openfda › Package ndc › 2216729-456-17
Openfda › Package ndc › 2316729-457-15
Openfda › Package ndc › 2416729-457-17
Openfda › Product ndc › 116729-447
Openfda › Product ndc › 216729-458
Openfda › Product ndc › 316729-448
Openfda › Product ndc › 416729-449
Openfda › Product ndc › 516729-451
Openfda › Product ndc › 616729-450
Openfda › Product ndc › 716729-452
Openfda › Product ndc › 816729-453
Openfda › Product ndc › 916729-454
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 #: D2401834, D2401982, Exp. Date 08/31/2026; D2402584, D2402585, D2402586, D2402588, D2402587, D2402589, Exp Date. 11/30/2026.
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

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Overview

  • Recalling FirmACCORD HEALTHCARE, INC.
  • StatusOngoing
  • Risk LevelClass II
  • DistributionNationwide within the United States
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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🚨 SAFETY ALERT: ACCORD HEALTHCARE, INC. - 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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https://therecallfile.com/recalls/levothyroxine-sodium-tablets-usp-50-mcg-0-05-mg-1000-count-bottles-rx/FDA-D-0776-2026
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Spread the WordLevothyroxine 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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PharmaceuticalUSFDA Drugs

Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.

ACCORD HEALTHCARE, INC.
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Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.

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Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).

Sep 2, 2026Hikma Pharmaceuticals USA INC.
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Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 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 16729-453-17.

ACCORD HEALTHCARE, INC.
FDA DrugsClass II

Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 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 16729-453-17.

Subpotent Drug

Sep 2, 2026ACCORD HEALTHCARE, INC.

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