Class II · Moderate risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications
Olanzapine Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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.
Affected NDC
33342-0068-07
Compare with the code on your package — it is the most precise check available.
Drug: Olanzapine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Olanzapine NDC 33342-0068 |
5 mg/1 | Tablet, Film Coated Oral |
Macleods Pharmaceuticals Limited | Rx |
- Recalling firm
- Macleods Pharmaceuticals Limited
- NDC code
- 33342-068-07
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0867-2026 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Olanzapine recalls
See all
Class II · Moderate risk
Olanzapine Orally Disintegrating Tablets
cGMP deviations: Temperature abuse
Class II · Moderate risk
Olanzapine single dose vial Lyophilized
cGMP deviations: Temperature abuse
Class II · Moderate risk
Olanzapine Tablets
cGmp Deviations
Class II · Moderate risk
Zyprexa Intramuscular
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Other recalls by Macleods Pharmaceuticals Limited
All 2026 recalls
Class III · Low risk
Famciclovir Tablets
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Class III · Low risk
Levothyroxine Sodium Tablets
Presence of a foreign substance: black hair found embedded in tablet.
Class II · Moderate risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications
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