Olanzapine Tablets recall (Macleods Pharmaceuticals Limited)
DrugClass IIIOngoing
Summary: Macleods Pharmaceuticals Limited is recalling 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.
What is being 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
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Lot: BOB22321A, Exp 07-31-2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0867-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | August 27, 2026 |
| Reported | September 30, 2026 |
| Company | Macleods Pharmaceuticals Limited |
| Company location | Tehsil Baddi, District Solan, India |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 22,032 30-count bottles |
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