CLASS II Drug recall · Reported 19 Jun 2019 · FDA Enforcement Report
Cough Syrup (Guaifenesin Syrup, USP) 200 mg recalled by Torrent Pharma
Torrent Pharma is recalling Cough Syrup (Guaifenesin Syrup, USP) 200 mg/, Alcohol free Non-Narcotic Expectorant, oz, 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 codes Lot #s: 17F022, Exp. 06/2019; 17G027, Exp. 07/2019; 17H021; 17H021A, Exp. 08/2019; 17J008, Exp. 09/2019; 17L001, Exp. 11/2019; 17M015, Exp. 12/2019; 18A018, Exp. 01/2020; 18B003; 18B008, Exp. 02/2020; 18C012, Exp. 03/2020; 18D005, Exp. 04/2020; 18F008; 18F043, Exp. 06/2020; 18G025; 18H004, Exp. 07/2020; 18H007; 18H016, Exp. 08/2020.
Quantity recalled 249,744 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-1368-2019
FDA event ID 82889
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
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
Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle, NDC: 0536-0825-85, Distributed by Rugby Laboratories, Livonia, MI 48152.
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: 17F022, Exp. 06/2019; 17G027, Exp. 07/2019; 17H021; 17H021A, Exp. 08/2019; 17J008, Exp. 09/2019; 17L001, Exp. 11/2019; 17M015, Exp. 12/2019; 18A018, Exp. 01/2020; 18B003; 18B008, Exp. 02/2020; 18C012, Exp. 03/2020; 18D005, Exp. 04/2020; 18F008; 18F043, Exp. 06/2020; 18G025; 18H004, Exp. 07/2020; 18H007; 18H016, Exp. 08/2020.
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 .
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