RecallReported September 30, 2026
Class III recall by Macleods Pharmaceuticals Limited
Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: M…
FDA's enforcement report of September 30, 2026 lists a Class III recall by Macleods Pharmaceuticals Limited of Tehsil Baddi, District Solan, India. Product: Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: M…. Status: Ongoing.
On the record
- Recalling firm
- Macleods Pharmaceuticals Limited
- Location
- Tehsil Baddi, District Solan, India
- Classification
- Class III
- Status
- Ongoing
- Recall number
- D-0867-2026
- Product type
- Drugs
- Brand names
- OLANZAPINE
- Generic names
- OLANZAPINE
- Recall initiated
- 2026-08-27
- Reported by FDA
- 2026-09-30
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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