Home / Recalls / Mylan Institutional, Inc. / D-0133-2025

D-0133-2025 Class II Ongoing

Recalled by Mylan Institutional, Inc. — Rockford, IL

FDA drug recall D-0133-2025 was initiated by Mylan Institutional, Inc. on Nov 19, 2024 and is designated Class II. Reason for recall: Subpotent and Superpotent Drug The recall status is ongoing. Affected quantity: 1,664 cartons.

Recall Details

Product Type: Drugs
Report Date: Dec 18, 2024
Initiation Date: Nov 19, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,664 cartons

Product Description

Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-443-20

Reason for Recall

Subpotent and Superpotent Drug

Distribution Pattern

Nationwide in the USA.

Code Information

Lot #: 3115893, Exp. Date 6/2025

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0133-2025
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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… (Mar 7, 2025)
D-0291-2025 Class II — Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose… (Mar 7, 2025)
D-0135-2025 Class II — Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton… (Nov 19, 2024)
D-0134-2025 Class II — Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton… (Nov 19, 2024)
D-0136-2025 Class II — Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton… (Nov 19, 2024)
D-0131-2025 Class II — Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10… (Nov 19, 2024)
D-0132-2025 Class II — Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton… (Nov 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… (Aug 17, 2020)
D-1576-2020 Class I — Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose… (Aug 17, 2020)