Reported Sep 30, 2026 · Ongoing · Updated Oct 6, 2026
Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ,…
Macleods Pharmaceuticals Limited
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Macleods Pharmaceuticals Limited · Village Theda · Tehsil Baddi, District Solan · N/A
Is this the product you have?
- Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only
- Manufactured ForMacleods Pharma USA, Inc. Princeton, NJ, 08540
- Manufactured byMacleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07
- Lot codes and dates
- Lot
BOB22321AExp 07-31-2027
- Lot
- Amount recalled
- 22,032 30-count bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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