Lanthanum carbonate chewable tablets recalled after failing a hardness specification
Cipla USA is recalling Lanthanum Carbonate chewable tablets, 1000mg, after the product failed stability specifications with an out of specification hardness test result.
What this means for you
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 out of specification stability result with no stated clinical consequence or reported harm.
Plain-English summary
Lanthanum Carbonate chewable tablets, 1000mg, supplied as 10 x 9 bottles per patient pack carton, are being recalled. The prescription product is manufactured by Invagen Pharmaceuticals, Inc., a subsidiary of Cipla Ltd, of Hauppauge, New York, for Exelan Pharmaceuticals, Inc. of Boca Raton.
The recall follows failed stability specifications: an out of specification result on the hardness test.
The recall covers lot NB240314, expiry 12/31/2025. The record does not state a quantity. Distribution was nationwide in the USA. The FDA has classified the action as Class II.
The record describes a stability testing failure rather than a reported patient harm. Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific pack is affected.
The recalled product
- Product
- Deep-brand PREMIUM Select Jamun KEEP FROZEN Net Wt. 12 oz. (340 g)
- Manufacturer
- CHETAK NEW YORK LLC
- Category
- Drug — Phosphate binder
- 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 (14)
- Lots: 24355
- 24359
- 25004
- 25060
- 25067
- 25080
- 25101
- 25123
- 25139
- 25141
- 25144
- 25150
- 25157
- 25191
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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