Cipla Recalls Fosfomycin Tromethamine Due to Impurity Specification Failures
Cipla USA, Inc. is recalling specific lots of Fosfomycin Tromethamine granules because they failed impurity and degradation specifications.
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: The recall is classified as Class II due to failed impurities and degradation specifications, a hazard that may cause temporary or medically reversible adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Cipla USA, Inc. is recalling Fosfomycin Tromethamine Granules for Oral Solution, 3 Grams, single-dose sachets. The product is a prescription-only medication manufactured by Cipla Ltd. in India for Cipla USA, Inc. The specific lot affected is 5KA0405, with an expiration date of 12/31/2026.
The recall was initiated because the product failed impurities and degradation specifications. This means the medication did not meet the required standards for chemical purity and stability.
The affected product was distributed nationwide in the United States. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or point of distribution for disposal or credit, as directed by the recalling firm.
The recalled product
- Product
- FOSFOMYCIN TROMETHAMINE (FOSFOMYCIN TROMETHAMINE)
- Brand
- FOSFOMYCIN TROMETHAMINE
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Antibiotic
- Hazard
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 (2)
- Lot#: 5KA0405
- Exp 12/31/2026.
Distribution
Distributed nationwide across the United States.
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