Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Is Olanzapine recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Olanzapine (21 total). Check the affected lots below.
Most common reason: Impurity / degradation (9 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Olanzapine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Olanzapine recalls in 2026
1 initiated in 2026, 21 in total — newest first
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
Class II · Moderate risk
Zyprexa Intramuscular
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Class III · Low risk
Olanzapine Orally Disintegrating Tablets
Subpotent
Class III · Low risk
Olanzapine Tablets
Failed Impurities/ Degradation Specifications
Class III · Low risk
Olanzapine Tablets
Failed Impurities/ Degradation Specifications
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Olanzapine tablets
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
Class III · Low risk
Olanzapine
Subpotent drug
Class III · Low risk
Olanzapine
Subpotent drug
Class III · Low risk
Olanzapine
Subpotent drug
Class III · Low risk
Olanzapine Orally Disintegrating Tablets 5 mg
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Class II · Moderate risk
Olanzapine Tablets
Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.
Class II · Moderate risk
Olanzapine
Labeling:Label Mixup; OLANZAPINE, Tablet 7.5 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 75 mg, NDC 00093081301, Pedigree: AD21790_73, EXP: 5/1/2014.
Class II · Moderate risk
OLANZapine Tablet
Labeling:Label Mixup; OLANZapine, Tablet, 7.5 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 175 mcg, NDC 00527135001, Pedigree: AD46265_37, EXP: 5/15/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD60272_73, EXP: 5/22/2014; MIRTAZAPINE, Tablet, 7.5 mg, NDC 59762141503, Pedigree: AD73525_55, EXP: 5/30/2014.
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