Olanzapine Recall: Macleods Pharma USA 5 mg Tablets
The FDA is recalling Olanzapine tablets, 5 mg, 30-count Rx bottles distributed nationwide in the United States. The recall is due to organic and unspecified impurities above specification in Lot BOB22321A, expiring 07-31-2027. Approximately 22,032 bottles were distributed; the product was manufactured for Macleods Pharma USA, Inc. in Princeton, NJ, and manufactured by Macleods Pharmaceuticals, Ltd in India.
| Brand | Macleods Pharmaceuticals Limited |
|---|---|
| Product | 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. |
| Reason | Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification. |
| Severity | low |
| Units affected | 22032 |
| Distribution | Nationwide in the USA |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any recalled Olanzapine tablets from Lot BOB22321A.
- Check your bottle for the lot number BOB22321A and expiration date; if it matches, discontinue use and contact your pharmacy or healthcare provider for guidance.
- Return the recalled product to the place of purchase or follow FDA recall instructions for disposal or replacement.
How to identify the recalled item
| Lot / date codes | Lot: BOB22321A, Exp 07-31-2027. |
|---|---|
| Lot / date codes | Lot: BOB22321A, Exp 07-31-2027. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.