Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0639-2022·Announced 2022-03-09

Olanzapine 10 mg tablets recalled due to cGMP deviations

Macleods Pharma USA is voluntarily recalling Olanzapine 10 mg tablets nationwide due to cGMP (current good manufacturing practices) deviations identified during manufacturing. The recall affects 3,672 bottles distributed across the United States.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for cGMP deviations—manufacturing quality control issues. The source text does not report any illnesses, injuries, or hospitalizations. Per the rubric, Class II recalls without reported adverse events typically score as Moderate (2).

Plain-English summary

Macleods Pharma USA Inc is voluntarily recalling Olanzapine Tablets, USP 10 mg in 30-count bottles due to cGMP deviations. The product was manufactured by Macleods Pharmaceuticals Ltd. in Baddi, Himachal Pradesh, India, and distributed nationwide within the United States.

The recall includes 3,672 bottles with lot numbers BOB42029A and BOB4202B, with an expiration date of 09/2022. The affected NDC number is 33342-070-07. The recall was initiated on February 16, 2022, following the firm's discovery of manufacturing deviations and was classified as FDA Class II on February 28, 2022.

Patients currently taking this medication should contact their healthcare provider or pharmacist for guidance. Do not stop taking olanzapine without medical advice, as abruptly discontinuing antipsychotic medication can be harmful. Patients should ask their pharmacist whether their specific medication is part of this recall.

The recalled product

Product: OLANZAPINE (OLANZAPINE)
Brand: OLANZAPINE
Manufacturer: Macleods Pharma Usa Inc
Category: Drug — Antipsychotic / Prescription
Hazard: cgmp-deviation
manufacturing-quality
Affected units: 3,672

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Lot #: BOB42029A
BOB4202B
Exp. Date 09/2022

UPCs (6)

0333342067074
0333342070074
0333342069078
0333342072078
0333342071071
0333342068071

Distribution

Distributed nationwide across the United States.

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