Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx
Lupin Pharmaceuticals recalls Cefdinir oral suspension (125mg/5mL) due to thickened suspension after reconstitution. Affected lots from January to May 2019. Consumers should check NDC codes and lot numbers for affected products.
Lower-risk recall
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Contact the company & request your remedy
What happened, in plain English
Lupin Pharmaceuticals is recalling certain Cefdinir oral suspension products because they become thick after reconstitution. This could affect how the medication works if the suspension isn't properly mixed. Read more at govinfonow.com/recall/39256-lupin-cefdinir-oral-suspension-recall-thick-suspension-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39256-lupin-cefdinir-oral-suspension-recall-thick-suspension-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0375-2019
Cite this page
“Lupin Cefdinir Oral Suspension Recall: Thick Suspension Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39256-lupin-cefdinir-oral-suspension-recall-thick-suspension-risk. Based on FDA recall #D-0375-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0375-2019%22&limit=1).
Why it’s dangerous
The suspension thickens after reconstitution, which may lead to improper medication dosing. This could affect the effectiveness of the antibiotic if the mixture isn't properly mixed.
Who’s affected
People who have the specific Cefdinir oral suspension products with the listed NDC codes and lot numbers. Prescribers and patients using these products are most at risk if the suspension becomes too thick.
How to tell if you have this one
Check the NDC codes: 68180-722-20 (60mL) or 68180-722-10 (100mL). Look for specific lot numbers and expiration dates listed in the recall notice.
- Brand
Lupin Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide within the United States- NDC
68180-722-20, 68180-722-10, 68180-722-04, 68180-722-05, 68180-723-20, 68180-723-10, 68180-723-04, 68180-723-05
| Recall number | Product, codes & lots |
|---|---|
| D-0375-2019 | 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; a) Lot #: F700329, F700330, F700328, Exp. January 2019; F700544, F700545, F700668, F700669, F700670, Exp. March 2019; F700958, Exp. April 2019 b) Lot #: F700327, F700392, F700393, Exp. January 2019; F700546, F700547, F700664, Exp. March 2019; F700967, Exp. April 2019, F701106, F701107, F701108, F701109, Exp. May 2019. |
| D-0376-2019 | 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; a) Lot #: F700343, F700344, F700345, F700346, F700347,F700376, F700377, F700415, F700146,F700417, F700418, Exp. Jan 2019; F700419, F700420, F700492, F700493,F700508,F700665, Exp. February 2019; F700784, Exp. April 2019; b) Lot #: F700324, F700325, F700326, Exp. January 2019; F700618, F700619, F700620, Exp. February 2019. |
What to do — step by step
Check Product Details
Identify the NDC code and lot number on your Cefdinir oral suspension bottle to see if it matches the recalled products.
Questions people ask
Is this product safe to use?
The recall is due to thickened suspension after reconstitution, which may affect dosing. If you have the recalled product, you should check the recall list to see if it's affected.
How do I know if my product is recalled?
Check the NDC code on the product label: 68180-722-20 for 60mL bottles or 68180-722-10 for 100mL bottles. Also check the lot numbers and expiration dates listed in the recall notice.
What should I do if I have the recalled product?
The recall does not include a specific remedy, so you should check the product details to see if it matches the recalled items. If it does, contact your healthcare provider for guidance.
Contact Lupin Pharmaceuticals
We’ve drafted a message you can send Lupin Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0375-2019 — Lupin Pharmaceuticals Lupin Pharmaceuticals Hello, I own a Lupin Pharmaceuticals that is covered by recall D-0375-2019 from Lupin Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0375-2019 (January 2, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0375-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.