Why it was recalled
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: BOB22321A, Exp 07-31-2027.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0867-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Aug 27, 2026
- FDA report date
- Sep 30, 2026
- Quantity
- 22,032 30-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharmaceuticals Limited
Original FDA data
Every field from FDA enforcement report D-0867-2026, exactly as published.
Show all FDA fields
- City
- Tehsil Baddi, District Solan
- Status
- Ongoing
- Country
- India
- Event ID
- 99773
- Address
- Village Theda
- Address (line 2)
- Post Office Lodhimajra
- Code information
- Lot: BOB22321A, Exp 07-31-2027.
- Report date
- Sep 30, 2026
- Product type
- Drugs
- Recall number
- D-0867-2026
- Classification
- Class III
- Recalling firm
- Macleods Pharmaceuticals Limited
- Product quantity
- 22,032 30-count bottles
- Reason for recall
- Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 27, 2026
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 22, 2026