OLANZAPINE Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleo Recall 2026
OLANZAPINEIssued August 27, 2026
OLANZAPINE 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 — recalled per FDA on 8/27/2026. Reason: Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification..
What to do about this recall
- Agency
- FDA
- Issued
- Aug 27, 2026
- Brand
- OLANZAPINE
- Distribution
- 1 states
- Lots affected
- 2
Steps to take for this recall
Stop using it
Take it out of rotation. Don't consume, wear, or operate.
Verify the match
Compare lot numbers, UPCs, and dates against your product.
Return or dispose
Follow the manufacturer's instructions to refund or safely dispose.
What's 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.
Why it was recalled
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Affected products & lot numbers2 lots called out
Affected Lot Numbers
Check your product label — do not use if your lot number appears below.
| Lot Number |
|---|
| Lot: BOB22321A |
| Exp 07-31-2027. |
Where was it sold1 state
Nationwide in the USA
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Frequently asked questions
Is the OLANZAPINE recall still active?
Yes, this recall is currently active as of August 27, 2026. Do not use or consume the affected product.
What lot numbers are affected?
Affected lot numbers: Lot: BOB22321A, Exp 07-31-2027.. Check the label on your product.
What should I do if I have the recalled OLANZAPINE?
Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.