CLASS II ONGOING Drug recall · Reported 25 Dec 2024 · FDA Enforcement Report

Olanzapine Tablets, USP 2.5 mg recalled by Macleods Pharmaceuticals

Macleods Pharmaceuticals is recalling Olanzapine Tablets, USP 2.5 mg, distributed nationwide in the US. The recall was initiated on 25 Nov 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot# BOB12318A Exp 07/31/2027
NDC33342-067, 33342-068, 33342-069, 33342-070, 33342-071, 33342-072
UPC0333342067074, 0333342070074, 0333342069078, 0333342072078, 0333342071071, 0333342068071
Quantity recalled15,744 30-count bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0154-2025
FDA event ID
95838
Recalling firm
Macleods Pharmaceuticals, Mumbai
Manufacturer
Macleods Pharmaceuticals Limited
Classification
Class II
Status
Ongoing
Recall initiated
25 Nov 2024
FDA classified
19 Dec 2024
Reported
25 Dec 2024
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Potency & Assay

Timeline

25 Nov 2024Recall initiated by company
19 Dec 2024Classified by FDA+24 days
25 Dec 2024Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Impurities/Degradation Specifications

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Failed Impurities/Degradation Specifications

Which lots are affected?

Lot# BOB12318A Exp 07/31/2027

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Macleods Pharmaceuticals

All 4
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIIOlanzapine Tablets, USP 5 mg recalled by Macleods PharmaceuticalsOlanzapineMacleods PharmaceuticalsPotency & AssayNationwide
DrugCLASS IIIFamciclovir Tablets, USP 500 mg recalled by Macleods PharmaceuticalsFamciclovirMacleods PharmaceuticalsPackaging DefectsNationwide
DrugCLASS IIILevothyroxine Sodium Tablets, USP 112 mcg (0.112mg) recalledLevothyroxine SodiumMacleods PharmaceuticalsOtherNationwide

Other Olanzapine recalls

All 16
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIIOlanzapine Tablets, USP 5 mg recalled by Macleods PharmaceuticalsOlanzapineMacleods PharmaceuticalsPotency & AssayNationwide
DrugCLASS IIOlanzapine Tablets, USP 10 mg recalled by Macleods Pharma UsaOlanzapineMacleods Pharma UsaManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIIOlanzapine Tablets, USP 2.5 mg recalled by Aurobindo Pharma USAAurobindo Pharma USAPotency & AssayNationwide
DrugCLASS IIIOlanzapine Tablets, USP 7.5 mg recalled by Aurobindo Pharma USAAurobindo Pharma USAPotency & AssayNationwide
DrugCLASS IIIOlanzapine Tablets, 20 mg recalled by Sun Pharmaceutical IndustriesSun Pharmaceutical IndustriesPotency & AssayNationwide