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

Phenobarbital Oral Solution, USP, 20 mg recalled by Torrent Pharma

Torrent Pharma is recalling Phenobarbital Oral Solution, USP, 20 mg per, 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: 17E007, Exp. 05/2019; 17F026, Exp. 06/2019; 17G015, Exp. 07/2019; 17K002; 17K026, Exp. 10/2019; 17M002, Exp. 12/2019; 18C020, Exp. 03/2020; 18D023, Exp. 04/2020; 18F009, Exp. 06/2020; 18K030, Exp. 10/2020.

Quantity recalled148,440 bottles

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-1365-2019
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 2019	Recall initiated by company
13 Jun 2019	Classified by FDA	+23 days
19 Jun 2019	Published 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

Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) bottle, NDC:16571-330-16, Manufactured by Bio-Pharm Inc., Levittown, PA 10957, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663.

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: 17E007, Exp. 05/2019; 17F026, Exp. 06/2019; 17G015, Exp. 07/2019; 17K002; 17K026, Exp. 10/2019; 17M002, Exp. 12/2019; 18C020, Exp. 03/2020; 18D023, Exp. 04/2020; 18F009, Exp. 06/2020; 18K030, Exp. 10/2020.

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.

Reported	Class	Recall	Company	Reason	Where
19 Jun 2019	CLASS II	Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Kid Kare Childrens Cough/Cold Liquid, Antihistamine recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Memantine Hydrochloride Oral Solution, 2 mg/mL recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Hyoscyamine Oral Drops 0.125 mg/mL recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Extra Action Cough Syrup (Guaifenesin recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Lactulose Solution, USP, For Oral or Rectal Administration recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Hemorrhoidal Suppositories (Phenylephrine HCl recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Children's Acetaminophen Liquid, 160 mg per, Fever and Pain recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Cough Syrup (Guaifenesin Syrup, USP) 200 mg recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Banophen Oral Solution, Sugar Free, Alcohol Free recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Hydrocodone Bitartrate and Homatropine Methylbromide Oral recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	RisperiDONE Oral Solution, USP, 1 mg/mL recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Hydrocodone Bitartrate and Homatropine Methylbromide Oral recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Anu-Med of Hemorrhoidal Suppositories recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Memantine Hydrochloride Oral Solution, 2 mg/mL recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Robafen Cough Formula Expectorant (guaifenesin USP 200 mg recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Acetic Acid Otic Solution recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Pseudoephedrine Oral Solution, 30 mg in each teaspoonful recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Children's Mapap Acetaminophen Liquid, Fever reducer recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Hydrocortisone Acetate Suppositories, 25 mg recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Laxative Suppositories (Bisacodyl USP, 10 mg) recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	RisperiDONE Oral Solution, USP, 1 mg/mL recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Robafen AC Oral Solution (Guaifenesin recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Pain & Fever Oral Solution (Acetaminophen 160 mg recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Guaifenesin AC Cough Syrup (Guaifenesin recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Lactulose Solution, USP, For Oral Administration recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Bisacodyl Suppositories, Brite Stock, Reese recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Robafen DM Cough Sugar-Free Clear Cough Expectorant recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Cetirizine HCL Oral Solution, USP 1mg/mL - BULK, PLD recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/, a) recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Hyoscyamine Sulfate Elixir 0.125 mg recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Allergy Liquid Antihistamine recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Pedia Relief Cough-Cold Oral Solution, Alcohol free recalled	Torrent Pharma	Sterility	Nationwide
19 Jun 2019	CLASS II	Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories recalled	Torrent Pharma	Sterility	Nationwide

More recalls from Torrent Pharma

All 84

Reported	Class	Recall	Company	Reason	Where
11 Jun 2025Drug	CLASS II	Fluoxetine Tablets, USP, 20 mg recalled by Torrent PharmaFluoxetine	Torrent Pharma	Nitrosamine Impurity	Nationwide
11 Jun 2025Drug	CLASS II	Fluoxetine Tablets, USP, 20 mg Carton ( Unit-dose) recalledFluoxetine	Torrent Pharma	Nitrosamine Impurity	Nationwide
11 May 2022Drug	CLASS II	Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg recalledPantoprazole Sodium	Torrent Pharma	Manufacturing (CGMP) Deviations	Nationwide
19 Jan 2022Drug	CLASS II	Carbamazepine Tablets, USP 200 mg recalled by Torrent PharmaCarbamazepine	Torrent Pharma	Potency & Assay	Nationwide
22 Dec 2021Drug	CLASS III	Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg recalled	Torrent Pharma	Potency & Assay	Nationwide

Other Phenobarbital recalls

All 18

Reported	Class	Recall	Company	Reason	Where
25 May 2022Drug	CLASS III	Phenobarbital Elixir, USP 20 mg/, 1 Pint recalled by Monarch PCM	Monarch PCM	Other	TN
13 Apr 2022Drug	CLASS II	Phenobarbital Sodium Injection, USP, 130 mg/mL recalledPhenobarbital Sodium	Vitae Enim Vitae Scientific	Sterility	Nationwide
13 Apr 2022Drug	CLASS II	Phenobarbital Sodium Injection, USP, 65mg/mL recalledPhenobarbital Sodium	Vitae Enim Vitae Scientific	Sterility	Nationwide
2 Jun 2021Drug	CLASS II	Phenobarbital Tablets, USP 32.4 mg recalled by Cardinal Health	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
17 Apr 2019Drug	CLASS II	Phenobarbital Oral Solution, USP 20 mg/, unit dose cup recalled by Lohxa	Lohxa	Other	MA, NY, WY