Home / Recalls / Mylan Institutional, Inc. / D-0291-2025

D-0291-2025 Class II Ongoing

Recalled by Mylan Institutional, Inc. — Rockford, IL

Recall Details

Product Type: Drugs
Report Date: March 26, 2025
Initiation Date: March 7, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,068 cartons

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot 3115773, Exp. 03/31/2025

Other recalls by Mylan Institutional, Inc.

D-0290-2025 Class II — Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Bli (March 7, 2025)
D-0132-2025 Class II — Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (1 (November 19, 2024)
D-0136-2025 Class II — Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (1 (November 19, 2024)
D-0131-2025 Class II — Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 (November 19, 2024)
D-0134-2025 Class II — Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (1 (November 19, 2024)
D-0133-2025 Class II — Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (1 (November 19, 2024)
D-0135-2025 Class II — Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (1 (November 19, 2024)
D-0601-2021 Class III — Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 ( (May 3, 2021)
D-1575-2020 Class I — Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dos (August 17, 2020)
D-1576-2020 Class I — Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Via (August 17, 2020)