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Stop using now Drug recall · FDA · Published August 13, 2015

Safecor Recalls Midazolam HCl Syrup Due to Cardboard Contaminant

Safecor Health recalls specific lots of Midazolam HCl Syrup unit dose cups due to a cardboard contaminant. Check your lot number and expiration date.

🇺🇸 FDA recall #D-0657-2016DrugSafecor Health ›
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Contact the company

Recalling firmSafecor Health, LLC317 New Boston St · Woburn, MA 01801-6231
✎ GovInfoNow plain-language explainer

Safecor Health, LLC is recalling Midazolam HCl Syrup (10 mg/5 mL) because a customer complaint revealed a small piece of cardboard inside one of the 5 mL unit dose cups. The recall affects 132 unit dose cups distributed in New York. Lot 932333 with an expiration date of 08/04/16 is specifically identified. Read more at govinfonow.com/recall/43859-safecor-health-llc-recalls-midazolam-hcl-syrup-10-mg-5.

Source Summary by GovInfoNow · govinfonow.com/recall/43859-safecor-health-llc-recalls-midazolam-hcl-syrup-10-mg-5 · Updated October 12, 2026 · FDA enforcement record: FDA #D-0657-2016

Cite this page

“Safecor Recalls Midazolam HCl Syrup Due to Cardboard Contaminant.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/43859-safecor-health-llc-recalls-midazolam-hcl-syrup-10-mg-5. Based on FDA recall #D-0657-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0657-2016%22&limit=1).

The FDA announced on 2015-08-13 that Safecor Health, LLC is recalling Midazolam HCl Syrup Unit Dose Cups due to the presence of a foreign substance. The recall affects 132 unit dose cups distributed in New York.

How to tell if you have it

  • Brand: Safecor Health
  • Product: Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups
  • UPC: 0054356605
  • Lot: 932333
  • Expiration: 08/04/16

The hazard

The recall was initiated after a customer complaint revealed that one unit dose cup contained a small piece of cardboard contaminant. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Safecor Health, LLC has had 11 other recalls on record since 2015-03-02. Recent examples include the 2026-08-13 Fluphenazine Elixir recall for failed stability specifications and the 2026-05-01 Vitamin B-Complex Liquid recall due to foreign particles. Other recent recalls of similar products include the 2026-03-20 MGC Health Honey Lemon Cough Drops recall for FDA quality concerns, the 2025-12-12 Merck Noxafil Powdermix recall for metal particulate risk, and the 2026-02-17 Harvard Drug Group Midodrine tablets recall due to defective packaging.

How to tell if you have this one

Look for Midazolam HCl Syrup, 10 mg/5 mL, packaged in 5 mL unit dose cups. Check for Lot number 932333 and an expiration date of 08/04/16. The product was distributed in New York.

  • Brand
    Safecor Health
  • Product
    Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Stop Using the Product

    Do not use any unit dose cups from Lot 932333 due to the risk of cardboard contamination.

  2. Check Your Inventory

    Verify if you have product with Lot number 932333 and expiration date 08/04/16.

Where it went and when

Where it was distributed

Distributed in New York.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “NY” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: New York.

Recall timeline

FDA terminated this recall 6 months after the firm started it.

1. Firm started the recall: Aug 13, 201512. FDA classified it Class II: Feb 10, 201623. Published in FDA’s Enforcement Report: Feb 17, 201634. FDA terminated the recall: Feb 25, 2016420152016
  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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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-0657-2016 (August 13, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0657-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 12, 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