Medications & Supplements/Prescription Drugs

Major Pharmaceuticals Lorazepam Tablets Recalled for Potential Sub-potency

Agency Publication Date: February 19, 2025

Summary

The Harvard Drug Group, doing business as Major Pharmaceuticals and Rugby Laboratories, is recalling approximately 204,155 cartons of Lorazepam Tablets (generic for Ativan). Routine stability testing revealed that these medications were sub-potent and failed impurities specifications, meaning the drug may not be as strong as intended. Using sub-potent medication can result in ineffective treatment for anxiety or other conditions for which Lorazepam is prescribed. The affected products were distributed nationwide and in Puerto Rico in unit-dose cartons containing 100 tablets.

Risk

Sub-potent medication may fail to provide the full therapeutic effect, potentially leading to a return of symptoms or worsening of the patient's medical condition. Additionally, the presence of impurities beyond the approved specifications can pose unknown health risks over time.

What You Should Do

This recall affects Major Pharmaceuticals Lorazepam Tablets, USP, in 0.5mg, 1mg, and 2mg strengths, sold in unit-dose cartons containing 100 tablets (10 blister packs of 10).
To determine if your product is affected, check the NDC numbers on the packaging: 0904-6007-61 (0.5mg), 0904-6008-61 (1mg), and 0904-6009-61 (2mg).
Check the lot number and expiration date printed on the carton or blister pack. See the Affected Products section below for the full list of affected codes.
If you have health concerns related to this medication, contact your healthcare provider or pharmacist immediately. Return any unused product to the place of purchase for a refund, throw it away, or contact Major Pharmaceuticals directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund.

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Lorazepam Tablets, USP (0.5mg)

Variants: 0.5mg strength, Unit Dose, 100 tablets per carton

Lot Numbers:

N01424 (Exp 03/31/2025)

N01425 (Exp 03/31/2025)

N01659 (Exp 08/31/2025)

N01660 (Exp 08/31/2025)

N01668 (Exp 09/30/2025)

N01679 (Exp 10/31/2025)

N01704 (Exp 10/31/2025)

N01745 (Exp 10/31/2025)

N01856 (Exp 02/28/2026)

N01973 (Exp 05/31/2026)

N02079 (Exp 08/31/2026)

NDC:

0904-6007-61

Drug product sourced from NDC 69315-904 Leading Pharma, LLC.

Product: Lorazepam Tablets, USP (1mg)

Variants: 1mg strength, Unit Dose, 100 tablets per carton

Lot Numbers:

N01419 (Exp 03/31/2025)

N01420 (Exp 03/31/2025)

N01421 (Exp 03/31/2025)

N01663 (Exp 06/30/2025)

N01664 (Exp 08/31/2025)

N01673 (Exp 09/30/2025)

N01688 (Exp 08/31/2025)

N01747 (Exp 11/30/2025)

N01748 (Exp 11/30/2025)

N01749 (Exp 11/30/2025)

N01792 (Exp 12/31/2025)

N01857 (Exp 02/28/2026)

N01974 (Exp 05/31/2026)

N02081 (Exp 08/31/2026)

NDC:

0904-6008-61

Drug product sourced from NDC 69315-905 Leading Pharma, LLC.

Product: Lorazepam Tablets, USP (2mg)

Variants: 2mg strength, Unit Dose, 100 tablets per carton

Lot Numbers:

N01422 (Exp 03/31/2025)

N01423 (Exp 03/31/2025)

N01661 (Exp 09/30/2025)

N01662 (Exp 09/30/2025)

N01746 (Exp 10/31/2025)

N01750 (Exp 10/31/2025)

N01876 (Exp 03/31/2026)

N01877 (Exp 03/31/2026)

N01899 (Exp 04/30/2026)

N01900 (Exp 04/30/2026)

N01975 (Exp 04/30/2026)

NDC:

0904-6009-61

Drug product sourced from NDC 69315-906 Leading Pharma, LLC.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96151

Status: Active

Manufacturer: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Sold By: Retail Pharmacies; Hospitals; Wholesalers

Manufactured In: United States

Units Affected: 3 products (82,281 cartons; 94,349 cartons; 27,525 cartons)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Major Pharmaceuticals Lorazepam Tablets, USP, in 0.5mg, 1mg, and 2mg strengths, sold in unit-dose cartons containing 100 tablets (10 blister packs of 10).

To determine if your product is affected, check the NDC numbers on the packaging: 0904-6007-61 (0.5mg), 0904-6008-61 (1mg), and 0904-6009-61 (2mg).

Check the lot number and expiration date printed on the carton or blister pack. See the Affected Products section below for the full list of affected codes.

If you have health concerns related to this medication, contact your healthcare provider or pharmacist immediately. Return any unused product to the place of purchase for a refund, throw it away, or contact Major Pharmaceuticals directly for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund.

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Lorazepam Tablets, USP (0.5mg)

Variants: 0.5mg strength, Unit Dose, 100 tablets per carton

Lot Numbers:

N01424 (Exp 03/31/2025)

N01425 (Exp 03/31/2025)

N01659 (Exp 08/31/2025)

N01660 (Exp 08/31/2025)

N01668 (Exp 09/30/2025)

N01679 (Exp 10/31/2025)

N01704 (Exp 10/31/2025)

N01745 (Exp 10/31/2025)

N01856 (Exp 02/28/2026)

N01973 (Exp 05/31/2026)

N02079 (Exp 08/31/2026)

NDC:

0904-6007-61

Drug product sourced from NDC 69315-904 Leading Pharma, LLC.

Product: Lorazepam Tablets, USP (1mg)

Variants: 1mg strength, Unit Dose, 100 tablets per carton

Lot Numbers:

N01419 (Exp 03/31/2025)

N01420 (Exp 03/31/2025)

N01421 (Exp 03/31/2025)

N01663 (Exp 06/30/2025)

N01664 (Exp 08/31/2025)

N01673 (Exp 09/30/2025)

N01688 (Exp 08/31/2025)

N01747 (Exp 11/30/2025)

N01748 (Exp 11/30/2025)

N01749 (Exp 11/30/2025)

N01792 (Exp 12/31/2025)

N01857 (Exp 02/28/2026)

N01974 (Exp 05/31/2026)

N02081 (Exp 08/31/2026)

NDC:

0904-6008-61

Drug product sourced from NDC 69315-905 Leading Pharma, LLC.

Product: Lorazepam Tablets, USP (2mg)

Variants: 2mg strength, Unit Dose, 100 tablets per carton

Lot Numbers:

N01422 (Exp 03/31/2025)

N01423 (Exp 03/31/2025)

N01661 (Exp 09/30/2025)

N01662 (Exp 09/30/2025)

N01746 (Exp 10/31/2025)

N01750 (Exp 10/31/2025)

N01876 (Exp 03/31/2026)

N01877 (Exp 03/31/2026)

N01899 (Exp 04/30/2026)

N01900 (Exp 04/30/2026)

N01975 (Exp 04/30/2026)

NDC:

0904-6009-61

Drug product sourced from NDC 69315-906 Leading Pharma, LLC.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96151

Status: Active

Manufacturer: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Sold By: Retail Pharmacies; Hospitals; Wholesalers

Manufactured In: United States

Units Affected: 3 products (82,281 cartons; 94,349 cartons; 27,525 cartons)

Distributed To: Nationwide