Mylan Pharmaceuticals Levothyroxine Sodium Tablets Recall

Why it was recalled

Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.

Product description

Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01

Lot numbers, UPCs & expiration codes

Lot 3037531 EXP 03/14 Lot 3038284 EXP 04/14

Where it was sold

Nationwide.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1084-2014
Classification: Class II
Status: Terminated
Recall initiated: Jan 14, 2014
FDA report date: Feb 19, 2014
Quantity: 138,970 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Mylan Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-1084-2014, exactly as published.

Show all FDA fields

City: Morgantown
State: WV
Status: Terminated
Country: United States
Event ID: 67399
Address: 781 Chestnut Ridge Rd
Code information: Lot 3037531 EXP 03/14 Lot 3038284 EXP 04/14
Postal code: 26505-2730
Report date: Feb 19, 2014
Product type: Drugs
Recall number: D-1084-2014
Classification: Class II
Recalling firm: Mylan Pharmaceuticals Inc.
Product quantity: 138,970 bottles
Termination date: Oct 14, 2015
Reason for recall: Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01
Distribution pattern: Nationwide.
Recall initiation date: Jan 14, 2014
Initial firm notification: Letter
Center classification date: Feb 10, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1084-2014, published Feb 19, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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