FDA Recall D-0291-2025

Mylan Institutional, Inc. · Rockford, IL

Class II Ongoing 433 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20.

Lot / code: Lot 3115773, Exp. 03/31/2025

Quantity: 1,068 cartons

Reason for recall

Super-Potent Drug: Out of specification potency results were obtained.

Recall record

Recall number: D-0291-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-03-07
Classified by FDA Center: 2025-03-20
FDA published: 2025-03-26
Recalling firm: Mylan Institutional, Inc.
Firm location: Rockford, IL

Drug identification

Brand name(s): LEVOTHYROXINE SODIUM
Generic name(s): LEVOTHYROXINE SODIUM
Manufacturer(s): Mylan Institutional Inc.
NDC(s): 51079-440, 51079-444, 51079-441, 51079-442, 51079-443, 51079-445
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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