CLASS II Drug recall · Reported 9 Mar 2016 · FDA Enforcement Report

Baclofen, 2.5 mg/mL INJ, in vial recalled by TexasStar Pharmacy

TexasStar Pharmacy is recalling Baclofen, 2.5 mg/mL INJ, in vial, distributed in Texas. The recall was initiated on 29 Dec 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 07142015#7192@1, Exp 09/12/2015; 09112015#7192@1, Exp 11/10/2015; 10082015#7192@9, Exp 12/07/2015; 11302015#71920@1, Exp 1/30/2015

Quantity recalled700 mL (7 vials of 100 mL)

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0733-2016
FDA event ID: 72958
Recalling firm: TexasStar Pharmacy, Plano, TX
Classification: Class II
Status: Terminated
Recall initiated: 29 Dec 2015
FDA classified: 2 Mar 2016
Reported: 9 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

29 Dec 2015	Recall initiated by company
2 Mar 2016	Classified by FDA	+64 days
9 Mar 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of assurance of sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023

Where it was distributed

Texas

Questions about this recall

Why was it recalled?

Lack of assurance of sterility

Which lots are affected?

Lot # 07142015#7192@1, Exp 09/12/2015; 09112015#7192@1, Exp 11/10/2015; 10082015#7192@9, Exp 12/07/2015; 11302015#71920@1, Exp 1/30/2015

Where was it sold?

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other Baclofen recalls

All 16

Reported	Class	Recall	Company	Reason	Where
24 Dec 2025Drug	CLASS II	Baclofen Tablets USP, 10 mg recalled by Golden State Medical SupplyBaclofen	Golden State Medical Supply	Other	Nationwide
22 Jan 2020Drug	CLASS II	Baclofen 2000MCG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
18 Dec 2019Drug	CLASS II	Baclofen and Clonidine HCL and Morphine Sulfate recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
7 Aug 2019Drug	CLASS II	Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe recalledGablofen	Piramal Critical Care	Potency & Assay	Nationwide
16 Mar 2016Drug	CLASS II	Baclofen 5000 mcg/ml, vol recalled by Hartley Medical Center	Hartley Medical Center Pharmacy	Sterility	Nationwide