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Stop using now Drug recall · FDA · Published December 29, 2015

TexasStar Pharmacy Recalls Baclofen Injections Due to Sterility Risk

TexasStar Pharmacy recalls specific lots of Baclofen 2.5 mg/mL injection vials due to a lack of sterility assurance. Check your lot numbers immediately.

🇺🇸 FDA recall #D-0733-2016DrugTexasStar Pharmacy ›
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Contact the company

Recalling firmTexasStar Pharmacy3033 W Parker Rd Ste 100 · Plano, TX 75023-8000
✎ GovInfoNow plain-language explainer

What happened, in plain English

TexasStar Pharmacy is recalling Baclofen, 2.5 mg/mL INJ, in 100 mL vials because there is a lack of assurance of sterility. The recall affects seven 100 mL vials distributed in Texas. Specific lot numbers and expiration dates are listed in the record. Read more at govinfonow.com/recall/43303-texasstar-pharmacy-recalls-baclofen-injections-due-to-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/43303-texasstar-pharmacy-recalls-baclofen-injections-due-to-sterility-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-0733-2016

Cite this page

“TexasStar Pharmacy Recalls Baclofen Injections Due to Sterility Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43303-texasstar-pharmacy-recalls-baclofen-injections-due-to-sterility-risk. Based on FDA recall #D-0733-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0733-2016%22&limit=1).

Why it’s dangerous

The product lacks assurance of sterility, meaning it may contain harmful microorganisms. Injecting a non-sterile drug can lead to serious infections or other complications for the patient.

Who’s affected

Patients in Texas who received Baclofen injections from TexasStar Pharmacy between the manufacturing dates associated with the recalled lots. Individuals using these specific vials are at risk of infection due to potential non-sterility.

How to tell if you have this one

Check if you have Baclofen, 2.5 mg/mL INJ in a 100 mL vial from TexasStar Pharmacy (Plano, Texas). Verify the lot number and expiration date against this list: Lot # 07142015#7192@1 (Exp 09/12/2015), Lot # 09112015#7192@1 (Exp 11/10/2015), Lot # 10082015#7192@9 (Exp 12/07/2015), and Lot # 11302015#71920@1 (Exp 1/30/2015).

  • Brand
    TexasStar Pharmacy
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Stop Using the Product

    Do not use the recalled Baclofen vials due to the sterility risk.

  2. Contact Your Provider

    Speak with your healthcare provider or pharmacist about alternative treatments and next steps.

Where it went and when

Where it was distributed

Distributed in Texas.

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: not listedNYRhode 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: yesTXFlorida: not listedFL

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

States: Texas.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Dec 29, 201512. FDA classified it Class II: Mar 2, 201623. Published in FDA’s Enforcement Report: Mar 9, 201634. FDA terminated the recall: Nov 17, 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-0733-2016 (December 29, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0733-2016 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