Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Feb 22, 2017 (10 years ago)

Ondansetron HCl all strengths

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Cause type: Labeling / mix-up

Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.

What was recalled

Ondansetron HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Drug: Ondansetron Category: Heartburn & Stomach Medication

Recalling firm
Advanced Pharma Inc.
Origin
TX, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0843-2017 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Ondansetron recalls

See all
Class II · Moderate risk

Ondansetron Orally Disintegrating Tablets

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

Ongoing Packaging defect Glenmark Pharmaceuticals Inc., USA NDC 68462-157-13 D-0246-2026
Class II · Moderate risk

Ondansetron ODT Tablets

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

Ongoing Packaging defect Preferred Pharmaceuticals, Inc. NDC 68788-8666-01 D-0239-2026

Other recalls by Advanced Pharma Inc.

All 2017 recalls