Ondansetron blister packs recalled because tablets are falling out
Preferred Pharmaceuticals is recalling 575 blister packs of Ondansetron ODT Tablets, 4mg, after the manufacturer reported that the blister packs are not fully sealed and tablets are falling out.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites an unsealed blister pack with no stated clinical consequence or reported harm.
Plain-English summary
Ondansetron ODT Tablets, USP 4mg, in 1 x 10 unit dose packs, manufactured by Glenmark Pharmaceuticals Limited and repackaged by Preferred Pharmaceuticals under NDC 68788-8666-01, are being recalled.
The reason given in the enforcement record is a defective container. Preferred Pharmaceuticals received a letter from the manufacturer, Glenmark, stating that the blister packs are not fully sealed and tablets are falling out. Preferred Pharmaceuticals purchased the finished product and repackaged it for sale.
The recall covers 575 foil blister packs of 1 x 10 from lots J1325J and I1725P, expiry 4/30/2027. Distribution was nationwide in the USA. The FDA has classified the action as Class II.
Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific pack is affected and arrange a replacement.
The recalled product
- Product
- Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Antiemetic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot: J1325J
- I1725P
- EXP Date: 4/30/2027.
Distribution
Distribution scope not specified by the agency.
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