Ohm Laboratories Leader Loratadine Orally Disintegrating Recall

Why it was recalled

Superpotent Drug: Out Of Specification (OOS) result for Assay.

Product description

Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7

Lot numbers, UPCs & expiration codes

Batch Numbers: 2617891, Exp 5/31/2016; 2625092, Exp 6/30/2016

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-0030-2016
Classification: Class III
Status: Terminated
Recall initiated: Jul 28, 2015
FDA report date: Oct 21, 2015
Quantity: 9,624 boxes
Recall type: Voluntary: Firm initiated
Recalling firm: Ohm Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-0030-2016, exactly as published.

Show all FDA fields

City: North Brunswick
State: NJ
Status: Terminated
Country: United States
Event ID: 71973
Address: 1385 Livingston Ave
Code information: Batch Numbers: 2617891, Exp 5/31/2016; 2625092, Exp 6/30/2016
Postal code: 08902-1829
Report date: Oct 21, 2015
Product type: Drugs
Recall number: D-0030-2016
Classification: Class III
Recalling firm: Ohm Laboratories, Inc.
Product quantity: 9,624 boxes
Termination date: Oct 28, 2016
Reason for recall: Superpotent Drug: Out Of Specification (OOS) result for Assay.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7
Distribution pattern: Nationwide.
Recall initiation date: Jul 28, 2015
Initial firm notification: Letter
Center classification date: Oct 15, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0030-2016, published Oct 21, 2015. 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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