Nebivolol tablets recalled over cross contamination with other products
Glenmark Pharmaceuticals is recalling 672 bottles of Nebivolol Tablets, 20 mg, over cross contamination with other products.
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Product tested positive Salmonella ."
Plain-English summary
Nebivolol Tablets, 20 mg, in 90-tablet bottles, manufactured by Glenmark Pharmaceuticals Limited of Pithampur, Madhya Pradesh, India, for Avkare of Pulaski, Tennessee, product of Italy, under NDC 42291-874-90, are being recalled.
The reason given in the enforcement record is cross contamination with other products.
The recall covers 672 90-count bottles from lot 17240988, expiry 05/31/2026. Distribution was nationwide in the United States. The FDA has classified the action as Class III, its least serious category.
Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.
The recalled product
- Product
- Deep-brand PREMIUM Select Methi Chopped KEEP FROZEN Net Wt. 10 oz. (283 g)
- Manufacturer
- CHETAK NEW YORK LLC
- Category
- Drug — Antihypertensive
- Affected units
- 3,509,532
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 (16)
- Lots: 24356
- 24358
- 24359
- 24360
- 24361
- 24362
- 24363
- 24365
- 24366
- 25001
- 25002
- 25003
- 25004
- 25005
- 25006
- 25008
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 52 recalled by CHETAK NEW YORK LLC under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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