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Class IIIOngoing

Macleods Pharmaceuticals Limited recalls Olanzapine Tablets

Recall date · record updated Sep 30, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Macleods Pharmaceuticals Limited
Reason
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Hazard
FDA Class III: not likely to cause adverse health consequences (FDA definition).
Who’s affected
Nationwide in the USA
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99773…

Products

  1. Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07.

    Codes/lots: Lot: BOB22321A, Exp 07-31-2027.Quantity: 22,032 30-count bottlesRecall no. D-0867-2026Class III

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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