Macleods Pharmaceuticals recall: Olanzapine Tablets
Macleods Pharmaceuticals Limited is recalling Olanzapine Tablets – 22,032 30-count bottles. The U.S. Food and Drug Administration published the recall on September 30, 2026; it began on August 27, 2026. Distributed nationwide.
Lower risk Class III means using the product is not likely to cause health problems; it breaks a labeling or manufacturing rule.
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| Product | Olanzapine Tablets |
| Brand | Macleods Pharmaceuticals |
| Company | Macleods Pharmaceuticals Limited |
| Type | Drugs |
| Classification | Class III |
| Recall date | August 27, 2026 |
| Published by FDA | September 30, 2026 |
| Quantity | 22,032 30-count bottles |
| Recall ID | 99773 |
Recalled products
- 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.
- FDA recall number
- D-0867-2026
- Codes, lots and dates
- Lot: BOB22321A, Exp 07-31-2027.
- Quantity
- 22,032 30-count bottles
- Classification
- Class III
Identifiers and details
- FDA event ID
- 99773
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Tehsil Baddi, District Solan, India
Why it was recalled
The reason the FDA lists: “Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Nationwide in the USA”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99773, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other drug recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 |  Ajanta Pharma recall: Ranolazine Extended-Release TabletsDrugs | Failed Dissolution Specifications: below specification Serious | FDA Class II |
| Oct 7, 2026 | Par Health recall: Buprenorphine HydrochlorideDrugs · 154210 bottles | Crystallization Serious | FDA Class II |
| Oct 7, 2026 | Apotex recall: Paroxetine Extended-Release TabletsDrugs | Failed dissolution specifications. Serious | FDA Class II |
| Oct 7, 2026 | TerSera Therapeutics recall: ZoladexDrugs · 296 cartons | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II |
| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is Macleods Pharmaceuticals Olanzapine Tablets recalled?
Yes. Macleods Pharmaceuticals Limited recalled it on August 27, 2026; FDA published it September 30, 2026 (Class III). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.