Cefixime oral suspension antibiotic recalled nationwide for subpotency
Lupin Pharmaceuticals is recalling Cefixime 100 mg/5 mL oral suspension due to subpotency discovered during stability testing. The affected lot (F201517) was distributed nationwide.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is subpotency (reduced drug efficacy) discovered through stability testing, representing a precautionary recall rather than an acute safety threat.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling one lot of Cefixime for Oral Suspension USP (100 mg/5 mL, 50 mL bottle, NDC 68180-405-01). The recall affects 4,554 bottles distributed nationwide.
The recall was initiated due to an out-of-specification (OOS) result observed during assay testing in an 18-month stability study. The affected product was determined to be subpotent, meaning it contains less than the labeled amount of active ingredient.
Patients currently taking this medication should contact their healthcare provider or pharmacist to determine whether they have been dispensed the recalled product. The lot number is F201517 with an expiration date of 11/30/2024.
Consumers or healthcare providers who have this product should stop use and contact Lupin Pharmaceuticals or the FDA for guidance on appropriate next steps.
The recalled product
- Product
- CEFIXIME (CEFIXIME)
- Brand
- CEFIXIME
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Affected units
- 4,554
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 #: F201517
- Exp 11/30/2024
UPCs (4)
- 0368180423089
- 0368180407034
- 0368180416081
- 0368180416111
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CEFIXIME
- HighCefixime Oral Suspension Recalled for Failed Content Uniformity Specifications
FDA (Drugs) · 2024-06-26
- HighLupin Pharmaceuticals Recalls Cefixime Suspension Over Failed Specifications
FDA (Drugs) · 2024-02-07
- ModerateCefixime Capsules 400 mg Recalled for Failed Impurities and Degradation
FDA (Drugs) · 2022-01-12
- ModerateCefixime Capsules 400 mg Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2021-11-17
- SevereLupin Recalls Subpotent Cefixime Oral Suspension Bottles Nationwide
FDA (Drugs) · 2021-05-26
Same manufacturer · Lupin Pharmaceuticals Inc.
See all →- ModerateLupin Recalls Clobetasol Propionate Cream for Content Uniformity Failures
FDA (Drugs) · 2026-09-02
- HighPrednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
FDA (Drugs) · 2026-07-08
- SevereGlucagon Emergency Kit Recalled for Manufacturing Process Deviation
FDA (Drugs) · 2026-07-08
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- ModerateSertraline tablets recalled because bottle seals are not adhering
FDA (Drugs) · 2025-12-17
Same hazard · subpotency
See all →- ModerateGood Neighbor Pharmacy Earwax Removal Drug Recalled for Low Potency
FDA (Drugs) · 2026-07-22
- ModerateNystatin Cream Recall Due to Low Potency Test Results
FDA (Drugs) · 2026-07-22
- ModerateFoster & Thrive Carbamide Peroxide 6.5% Recalled for Subpotent Strength
FDA (Drugs) · 2026-07-22
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- ModerateMeijer Earwax Removal Kit Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22
Similar recalls
- ModerateLupin Recalls Cefixime Oral Suspension Due to Low Potency
FDA (Drugs) · 2020-04-29
- SevereLupin Recalls Subpotent Cefixime Oral Suspension Bottles Nationwide
FDA (Drugs) · 2021-05-26
- HighLupin Pharmaceuticals Recalls Cefixime Suspension Over Failed Specifications
FDA (Drugs) · 2024-02-07
- HighCefixime Oral Suspension Recalled for Failed Content Uniformity Specifications
FDA (Drugs) · 2024-06-26
- SevereLupin Recalls Cefdinir Powder for Oral Suspension Due to Superpotency
FDA (Drugs) · 2018-04-25
- ModerateLupin Recalls Suprax Cefixime Oral Suspension Due to Impurity Failure
FDA (Drugs) · 2014-04-09