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 notice · announced September 30, 2026 · Macleods Pharmaceuticals Limited

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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 for recall

Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot: BOB22321A, Exp 07-31-2027.
Quantity: 22,032 30-count bottles
Status: Ongoing
Products in this recall event:
- 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 (D-0867-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.