The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1349-2019·Announced 2019-06-19

Torrent Pharma Recalls Robafen Cough Formula Due to Potential Bacterial Contamination

Torrent Pharma is recalling Robafen Cough Formula Expectorant due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves potential contamination with specific bacterial pathogens, which aligns with the rubric criteria for Severe severity.

Plain-English summary

Torrent Pharma Inc is recalling Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL) in 4 Fl. oz. and One Pint bottles. The recall involves 984,888 bottles distributed by Major Pharmaceuticals. The product was distributed to 9 distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States.

The recall is being conducted due to cGMP deviations that resulted in potential product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii). The agency has classified this as a Class II recall.

Consumers should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. If the product matches the recalled lots, consumers should stop using it and contact the distributor or manufacturer for instructions on return or disposal.

The recalled product

Product
Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-0061-00, b) One Pint ( 473 mL) bottle, NDC: 0904-0061-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.
Manufacturer
Torrent Pharma Inc
Category
Drug — Cough Medicine
Hazard
Affected units
984,888

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot #s: a) 17F003
  • Exp. 06/2019
  • 17J011
  • Exp. 09/2019
  • 17K018
  • 17K020
  • Exp. 10/2019
  • 17M014
  • 17M034
  • Exp. 12/2019
  • 18A035
  • Exp. 01/2020
  • 18B022
  • 18B027
  • Exp. 02/2020
  • 18C036
  • Exp. 03/2020
  • 18D009
  • 18D024
  • Exp. 04/2020. b) 17G018

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 41 recalled by Torrent Pharma Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 41 products in this recall →

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