Cefdinir recalls: 11 FDA reports
Recalls involving Cefdinir. What was wrong with each batch, and how the FDA graded the risk.
11Reports
0Class I
0Ongoing
2024-06-05Most 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.
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Ph
D-0518-2024 · Class II · reported 2024-06-05 · Terminated
- Why it was recalled
- Defective container: lack of seal integrity.
- Product
- Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04
- Where it went
- USA Nationwide
- How much
- 51,006 bottles
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured f
D-0496-2024 · Class II · reported 2024-05-22 · Terminated
- Why it was recalled
- Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
- Product
- Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04
- Where it went
- USA nationwide
- How much
- 17,070 bottles
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured f
D-0497-2024 · Class II · reported 2024-05-22 · Terminated
- Why it was recalled
- Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
- Product
- Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04
- Where it went
- USA nationwide
- How much
- 17,040 bottles
Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Phar
D-1406-2020 · Class II · reported 2020-07-29 · Terminated
- Why it was recalled
- Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
- Product
- Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20
- Where it went
- U.S.A. Nationwide
- How much
- 35,928 bottles
Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals,
D-0305-2020 · Class III · reported 2019-11-13 · Terminated
- Why it was recalled
- Presence of Foreign substance: identified as a dead ant.
- Product
- Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-723-10
- Where it went
- Product was distributed to major distributors/wholesalers throughout the United States.
- How much
- 30,516 bottles
Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle
D-0306-2020 · Class III · reported 2019-11-13 · Terminated
- Why it was recalled
- Presence of Foreign substance: identified as a dead ant.
- Product
- Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA
- Where it went
- Product was distributed to major distributors/wholesalers throughout the United States.
- How much
- a) 4074 bottles b) 30,300 bottles
Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured f
D-1320-2019 · Class II · reported 2019-06-05 · Terminated
- Why it was recalled
- Complaint received of metal piece identified in the product bottle prior to the reconstitution.
- Product
- Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046 India. NDC 68180-723-20
- Where it went
- Distributed Nationwide in the USA
- How much
- 18,408, 60 mL bottles
Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10
D-0375-2019 · Class II · reported 2019-01-16 · Terminated
- Why it was recalled
- CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
- Product
- Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
- Where it went
- Nationwide within the United States
- How much
- 287,784 bottles
Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10
D-0376-2019 · Class II · reported 2019-01-16 · Terminated
- Why it was recalled
- CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
- Product
- Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
- Where it went
- Nationwide within the United States
- How much
- 287,784 bottles
Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100
D-0684-2018 · Class II · reported 2018-04-25 · Terminated
- Why it was recalled
- Superpotent Drug
- Product
- Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs ( 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
- Where it went
- Nationwide
- How much
- 40,824 bottles
Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (N
D-247-2013 · Class II · reported 2013-04-17 · Terminated
- Why it was recalled
- Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.
- Product
- Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-4136-73), Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960.
- Where it went
- Nationwide
- How much
- 62,187 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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