Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted) recall
FDA recall D-0497-2024 · initiated Apr 24, 2024
Lupin Pharmaceuticals Inc. recalled Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted) in Apr 2024 — an FDA Class II recall (D-0497-2024) because Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 17,040 bottles
Details
- 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
- Recalling company
- Lupin Limited
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide
- Initiated
- Apr 24, 2024
- FDA report date
- May 22, 2024
Frequently asked
- Was Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted) recalled?
- Lupin Pharmaceuticals Inc. recalled Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted) in Apr 2024 — an FDA Class II recall (D-0497-2024) because Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted) recalled?
- Per the FDA enforcement record, the reason for recall D-0497-2024 was: Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
- Is a recalled Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted) are affected?
- Distributed: USA nationwide. The recall covers these lots — Lot # F305292, Exp 8/30/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0497-2024.