Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Olanzapine Orally Disintegrating Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32
Affected NDC
59746-0306-32
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 59746-0306 |
5 mg/1 | Tablet, Orally Disintegrating Oral |
Jubilant Cadista Pharmacuticals Inc. | Rx |
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- NDC code
- 59746-0306-32
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0066-2021 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Olanzapine recalls
See all
Class II · Moderate risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications
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
Other recalls by Jubilant Cadista Pharmaceuticals, Inc.
All 2020 recalls
Class III · Low risk
Prochlorperazine Maleate Tablets
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Class II · Moderate risk
Irbesartan Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Irbesartan Tablets
Failed dissolution specifications.
Class III · Low risk
Methylprednisolone Tablets
Subpotent
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