CLASS II Drug recall · Reported 19 Jun 2019 · FDA Enforcement Report

Bisacodyl Suppositories, Brite Stock, Reese recalled by Torrent Pharma

Torrent Pharma is recalling Bisacodyl Suppositories, Brite Stock, Reese, distributed nationwide in the US. The recall was initiated on 21 May 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #s: 17J003, Exp. 09/2019; 18A026, Exp. 01/2020; 18E031, Exp. 05/2020.
Quantity recalledN/A

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-1385-2019
FDA event ID
82889
Recalling firm
Torrent Pharma, Levittown, PA
Classification
Class II
Status
Terminated
Recall initiated
21 May 2019
FDA classified
13 Jun 2019
Reported
19 Jun 2019
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

21 May 2019Recall initiated by company
13 Jun 2019Classified by FDA+23 days
19 Jun 2019Published in enforcement report+6 days

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

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

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

Bisacodyl Suppositories, Brite Stock, Reese.

Where it was distributed

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

Nationwide

Questions about this recall

Why was it recalled?

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Which lots are affected?

Lot #s: 17J003, Exp. 09/2019; 18A026, Exp. 01/2020; 18E031, Exp. 05/2020.

Where was it sold?

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

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 products in this recall event

40 other products · FDA event 82889

This product is part of a recall event; the main page for the event is Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IINasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg recalledTorrent PharmaSterilityNationwide
CLASS IIKid Kare Childrens Cough/Cold Liquid, Antihistamine recalledTorrent PharmaSterilityNationwide
CLASS IIMemantine Hydrochloride Oral Solution, 2 mg/mL recalledTorrent PharmaSterilityNationwide
CLASS IIHyoscyamine Oral Drops 0.125 mg/mL recalled by Torrent PharmaTorrent PharmaSterilityNationwide
CLASS IIExtra Action Cough Syrup (Guaifenesin recalled by Torrent PharmaTorrent PharmaSterilityNationwide
CLASS IILactulose Solution, USP, For Oral or Rectal Administration recalledTorrent PharmaSterilityNationwide
CLASS IIHemorrhoidal Suppositories (Phenylephrine HCl recalled by Torrent PharmaTorrent PharmaSterilityNationwide
CLASS IIChildren's Acetaminophen Liquid, 160 mg per, Fever and Pain recalledTorrent PharmaSterilityNationwide
CLASS IICough Syrup (Guaifenesin Syrup, USP) 200 mg recalled by Torrent PharmaTorrent PharmaSterilityNationwide
CLASS IIBanophen Oral Solution, Sugar Free, Alcohol Free recalledTorrent PharmaSterilityNationwide
CLASS IIHydrocodone Bitartrate and Homatropine Methylbromide Oral recalledTorrent PharmaSterilityNationwide
CLASS IIRisperiDONE Oral Solution, USP, 1 mg/mL recalled by Torrent PharmaTorrent PharmaSterilityNationwide
CLASS IIHydrocodone Bitartrate and Homatropine Methylbromide Oral recalledTorrent PharmaSterilityNationwide
CLASS IICetirizine Hydrochloride Oral Solution, USP 1 mg/mL recalledTorrent PharmaSterilityNationwide
CLASS IIAnu-Med of Hemorrhoidal Suppositories recalled by Torrent PharmaTorrent PharmaSterilityNationwide
CLASS IIMemantine Hydrochloride Oral Solution, 2 mg/mL recalledTorrent PharmaSterilityNationwide
CLASS IIRobafen Cough Formula Expectorant (guaifenesin USP 200 mg recalledTorrent PharmaSterilityNationwide
CLASS IIAcetic Acid Otic Solution recalled by Torrent PharmaTorrent PharmaSterilityNationwide
CLASS IIPseudoephedrine Oral Solution, 30 mg in each teaspoonful recalledTorrent PharmaSterilityNationwide
CLASS IIGuaifenesin DAC Oral Solution, Sugar free, (Guaifenesin recalledTorrent PharmaSterilityNationwide
CLASS IIChildren's Mapap Acetaminophen Liquid, Fever reducer recalledTorrent PharmaSterilityNationwide
CLASS IIHydrocortisone Acetate Suppositories, 25 mg recalled by Torrent PharmaTorrent PharmaSterilityNationwide
CLASS IILaxative Suppositories (Bisacodyl USP, 10 mg) recalled by Torrent PharmaTorrent PharmaSterilityNationwide
CLASS IIRisperiDONE Oral Solution, USP, 1 mg/mL recalled by Torrent PharmaTorrent PharmaSterilityNationwide
CLASS IIRobafen AC Oral Solution (Guaifenesin recalled by Torrent PharmaTorrent PharmaSterilityNationwide
CLASS IIPain & Fever Oral Solution (Acetaminophen 160 mg recalledTorrent PharmaSterilityNationwide
CLASS IICyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg recalledTorrent PharmaSterilityNationwide
CLASS IIGuaifenesin AC Cough Syrup (Guaifenesin recalled by Torrent PharmaTorrent PharmaSterilityNationwide
CLASS IILactulose Solution, USP, For Oral Administration recalledTorrent PharmaSterilityNationwide
CLASS IICetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only recalledTorrent PharmaSterilityNationwide
CLASS IIRobafen DM Cough Sugar-Free Clear Cough Expectorant recalledTorrent PharmaSterilityNationwide
CLASS IICetirizine HCL Oral Solution, USP 1mg/mL - BULK, PLD recalledTorrent PharmaSterilityNationwide
CLASS IIDiphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/, a) recalledTorrent PharmaSterilityNationwide
CLASS IIRobafen DM Syrup (Dextromethorphan HBr, USP 20 mg recalledTorrent PharmaSterilityNationwide
CLASS IIPhenobarbital Oral Solution, USP, 20 mg recalled by Torrent PharmaTorrent PharmaSterilityNationwide
CLASS IIHyoscyamine Sulfate Elixir 0.125 mg recalled by Torrent PharmaTorrent PharmaSterilityNationwide
CLASS IIAllergy Liquid Antihistamine recalled by Torrent PharmaTorrent PharmaSterilityNationwide
CLASS IINasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) recalledTorrent PharmaSterilityNationwide
CLASS IIPedia Relief Cough-Cold Oral Solution, Alcohol free recalledTorrent PharmaSterilityNationwide
CLASS IIBiscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories recalledTorrent PharmaSterilityNationwide

More recalls from Torrent Pharma

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