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.
Class III · Ongoing
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
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Affected lots / codes — check yours against thisLot: BOB22321A, Exp 07-31-2027.
- Recalling firm
- Macleods Pharmaceuticals Limited, Tehsil Baddi, District Solan,
- Classification
- Class III (unlikely to cause harm)
- Status
- Ongoing
- Quantity
- 22,032 30-count bottles
- Distribution
- Nationwide in the USA
- Recall initiated
- August 27, 2026
- Classified
- September 22, 2026
- Initiation
- Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA
enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0867-2026%22
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0867-2026%22
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Important. Recalls target specific lots and codes — compare the affected lots
above against your own product. This page reproduces public FDA data for readability;
EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →