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Stop using now Drug recall · FDA · Published March 26, 2021

Lupin Recalls Cefprozil Oral Suspension Due to Superpotency

Lupin Pharmaceuticals recalls specific lots of Cefprozil for Oral Suspension USP, 250mg/5mL, due to superpotent drug hazards. Check your NDC and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0332-2021DrugLupin Pharmaceuticals ›
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Recalling firmLupin Pharmaceuticals Inc.Harborplace Tower, 111 S Calvert St Fl 21st · Baltimore, MD 21202-6174
✎ GovInfoNow plain-language explainer

Lupin Pharmaceuticals Inc. is recalling Cefprozil for Oral Suspension USP, 250mg/5mL, because the product is classified as a superpotent drug. The recall affects specific bottles with NDCs 68180-402-01, 68180-402-02, and 68180-402-03 manufactured for Lupin Pharmaceutical, Inc. in Baltimore, MD. The record does not specify the exact remedy or steps consumers should take. Read more at govinfonow.com/recall/36245-lupin-recalls-cefprozil-oral-suspension-due-to-superpotency.

Source Summary by GovInfoNow · govinfonow.com/recall/36245-lupin-recalls-cefprozil-oral-suspension-due-to-superpotency · Updated October 11, 2026 · FDA enforcement record: FDA #D-0332-2021

Cite this page

“Lupin Recalls Cefprozil Oral Suspension Due to Superpotency.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36245-lupin-recalls-cefprozil-oral-suspension-due-to-superpotency. Based on FDA recall #D-0332-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0332-2021%22&limit=1).

Lupin Pharmaceuticals Inc. recalled Cefprozil for Oral Suspension USP on March 26, 2021, due to superpotent drug hazards, the FDA said. The voluntary Class II recall affects specific lots of the antibiotic suspension distributed nationwide.

How to tell if you have it

  • Brand: Lupin Pharmaceuticals
  • Product: Cefprozil Oral Suspension USP, 250mg/5mL
  • NDC 68180-402-01: 50 mL bottles (when mixed), Lot F801122, exp. June 2021
  • NDC 68180-402-02: 75 mL bottles (when mixed), Lot F801123, exp. June 2021
  • NDC 68180-402-03: 100 mL bottles (when mixed), Lot F801124, exp. June 2021

The hazard

The recall addresses superpotent drug issues with the Cefprozil for Oral Suspension USP, according to the FDA.

Context

GovInfoNow's records show Lupin Pharmaceuticals Inc. has 90 other recalls on record since 2013-01-31. Other recent recalls of similar products include Lupin Clobetasol Cream Recall (2026-08-03), Lupin Glucagon Emergency Kit Recall (2026-06-23), and Lupin prednisolone acetate ophthalmic suspension recall (2026-06-04). Other recent recalls of similar products include Wells Pharma Fentanyl Citrate Injectable Solution Recall (2026-04-01), Baxter Clindamycin Injection Recall (2026-08-06), and Gasco Isopropyl Alcohol 70% Recall (2026-05-29).

How to tell if you have this one

Check your bottle for NDC numbers 68180-402-01 (50 mL), 68180-402-02 (75 mL), or 68180-402-03 (100 mL). Verify the lot numbers: F801122, F801123, or F801124. All affected lots have an expiration date of June 2021.

  • Brand
    Lupin Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Bottle

    Verify if your Cefprozil bottle has one of the listed NDCs and lot numbers with a June 2021 expiration date.

  2. Contact Healthcare Provider

    Consult your doctor or pharmacist regarding the superpotent drug classification and appropriate next steps, as the specific remedy is not stated in the record.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 9 months after the firm started it.

1. Firm started the recall: Mar 26, 202112. FDA classified it Class II: Apr 12, 202123. Published in FDA’s Enforcement Report: Apr 21, 202134. FDA terminated the recall: Dec 16, 202142021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Other Lupin Pharmaceuticals recalls

Lupin Pharmaceuticals Inc. recalls Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL
August 3, 2026Lupin Pharmaceuticals Inc. recalls Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL
June 23, 2026Lupin Pharmaceuticals Inc. recalls prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC
June 4, 2026Lupin Pharmaceuticals Inc. recalls Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108,
April 24, 2026Lupin Pharmaceuticals Inc. recalls Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only,
November 13, 2025Lupin Pharmaceuticals Inc. recalls Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals,
November 5, 2025

Keep exploring

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-0332-2021 (March 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0332-2021 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA