Cefixime recalls: 7 FDA reports
Recalls involving Cefixime. What was wrong with each batch, and how the FDA graded the risk.
7Reports
0Class I
0Ongoing
2024-09-04Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals,
D-0648-2024 · Class II · reported 2024-09-04 · Terminated
- Why it was recalled
- Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
- Product
- Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
- Where it went
- USA nationwide.
- How much
- 4554 bottles
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactu
D-0559-2024 · Class II · reported 2024-06-26 · Terminated
- Why it was recalled
- Failed Content Uniformity Specifications
- Product
- Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC 68180-407-03
- Where it went
- Nationwide in the US
- How much
- 3,552 bottles
Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc.,
D-0274-2024 · Class II · reported 2024-02-07 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
- Where it went
- Nationwide in the USA
- How much
- 4,608 Bottles
Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India,
D-0359-2022 · Class II · reported 2022-01-12 · Terminated
- Why it was recalled
- Failed impurities/degradation specifications
- Product
- Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50
- Where it went
- USA nationwide.
- How much
- 42,698 bottles
Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400
D-0229-2022 · Class II · reported 2021-11-17 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50
- Where it went
- Nationwide
- How much
- 4104 bottles
Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceutical
D-0390-2021 · Class II · reported 2021-05-26 · Terminated
- Why it was recalled
- Subpotent Drug
- Product
- Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 462 046, India, NDC 68180-405-01
- Where it went
- Nationwide within the United States
- How much
- 3,138 bottles
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore,
D-1252-2020 · Class II · reported 2020-04-29 · Terminated
- Why it was recalled
- Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
- Product
- Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01
- Where it went
- Nationwide with the United States and Puerto Rico.
- How much
- 4,518 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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