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FDA recall 99773: Macleods Pharmaceuticals Limited: Olanzapine Tablets

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FDARecall 99773Medicines

What to do

The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.

Read the official notice on accessdata.fda.gov (opens in a new tab)

Hazard

Why it was recalled

Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Text from FDA, unedited.

FDA classification: Class III. Use is not likely to cause adverse health consequences. Status: Ongoing.

Is it yours? Products and codes

  • 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 or code
    Lot: BOB22321A, Exp 07-31-2027.
    FDA recall number
    D-0867-2026
    Quantity
    22,032 30-count bottles

Distribution (FDA): Nationwide in the USA

About this record

Issued by
U.S. Food and Drug Administration
Firm
Macleods Pharmaceuticals Limited
Title
Composed by Recalls Watch from fields of the record; FDA records have no title.

If someone was hurt or swallowed something: call 911, or Poison Help at 1-800-222-1222.

About this recall

What is the hazard?

FDA states: “Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.”

What should I do if I have this product?

The FDA record of this recall has no instruction for consumers. Compare the lot codes on the notice with your product and follow the notice of the firm. The official report is linked on this page.

How do I know if my product is included?

Compare the lot or code printed on your product with the codes FDA lists on this notice, product by product.

When was this recall published?

FDA published recall 99773 on September 30, 2026.

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