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Class II: temporary or reversible health riskOngoing

Macleods Pharmaceuticals Olanzapine Tablets Recall

Olanzapine Tablets, USP 2

Macleods Pharmaceuticals Ltd

Risk level
Class II
Reported by FDA
Dec 25, 2024
Recall ID
D-0154-2025
Check your lot numberHow we source this data

Summary

Macleods Pharmaceuticals recalled Olanzapine Tablets starting Nov 25, 2024. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0154-2025 on Dec 25, 2024. Reason: Failed Impurities/Degradation Specifications. Status: Ongoing.

Why it was recalled

Failed Impurities/Degradation Specifications

Product description

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.

Lot numbers, UPCs & expiration codes

Lot# BOB12318A Exp 07/31/2027

Where it was sold

Nationwide in the USA

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-0154-2025
Classification
Class II
Status
Ongoing
Recall initiated
Nov 25, 2024
FDA report date
Dec 25, 2024
Quantity
15,744 30-count bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Macleods Pharmaceuticals Ltd

Original FDA data

Every field from FDA enforcement report D-0154-2025, exactly as published.

Show all FDA fields
City
Mumbai
Status
Ongoing
Country
India
Event ID
95838
Address
304 Atlanta Arcade
Address (line 2)
Church Road
Code information
Lot# BOB12318A Exp 07/31/2027
Report date
Dec 25, 2024
Product type
Drugs
Recall number
D-0154-2025
Classification
Class II
Recalling firm
Macleods Pharmaceuticals Ltd
Product quantity
15,744 30-count bottles
Reason for recall
Failed Impurities/Degradation Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.
Distribution pattern
Nationwide in the USA
Recall initiation date
Nov 25, 2024
Initial firm notification
Letter
Center classification date
Dec 19, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0154-2025, published Dec 25, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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