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Class III · Lower riskActive recall

Olanzapine

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot: BOB22321A, Exp 07-31-2027.
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMacleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA foreign manufacturer
Brand nameOLANZAPINE
Generic nameOLANZAPINE
Active ingredient(s)OLANZAPINE
Distributed by / forMacleods Pharma USA, Inc. Princeton, NJ, 08540;
NDC33342-068-07
Show the full FDA record
Full product labelOlanzapine 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.
Recalling firmMacleods Pharmaceuticals Limited
DistributionNationwide in the USA
Quantity22,032 30-count bottles
Recall initiated2026-08-27
Report date2026-09-30
Recall completed—
Recall numberD-0867-2026
ClassificationClass III
FDA statusOngoing
Origin on fileTehsil Baddi, District Solan India

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.