FDA Drug recall D-0867-2026
Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc
- FDA Drug
- Class III
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class III recall of Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc by Macleods Pharmaceuticals, citing failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0867-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-08-27 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Macleods Pharmaceuticals |
| Distribution | US |
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.
Identifiers
| ndc | 33342-067-07 |
|---|---|
| ndc | 33342-067-44 |
| ndc | 33342-067-12 |
| ndc | 33342-067-11 |
| ndc | 33342-068-07 |
| ndc | 33342-068-44 |
| ndc | 33342-068-12 |
| ndc | 33342-068-11 |
| ndc | 33342-069-07 |
| ndc | 33342-069-44 |
| ndc | 33342-069-12 |
| ndc | 33342-069-11 |
| ndc | 33342-070-07 |
| ndc | 33342-070-15 |
| ndc | 33342-070-12 |
| ndc | 33342-070-44 |
| ndc | 33342-070-11 |
| ndc | 33342-071-07 |
| ndc | 33342-071-15 |
| ndc | 33342-071-12 |
| ndc | 33342-071-44 |
| ndc | 33342-071-11 |
| ndc | 33342-072-07 |
| ndc | 33342-072-15 |
| ndc | 33342-072-12 |
| ndc | 33342-072-44 |
| ndc | 33342-072-11 |
| code_info | Lot: BOB22321A, Exp 07-31-2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Other recalls by Macleods Pharmaceuticals
- Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmace…
FDA Drug · Class III · 2025-07-16 · Macleods Pharmaceuticals - Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc
FDA Drug · Class III · 2025-06-18 · Macleods Pharmaceuticals - Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc
FDA Drug · Class II · 2024-12-25 · Macleods Pharmaceuticals
All Macleods Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0867-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.