Torrent Pharma Recalls Guaifenesin DAC Oral Solution Due to Contamination
Torrent Pharma Inc. is recalling specific lots of Guaifenesin DAC Oral Solution 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 involving significant health risks.
Plain-English summary
Torrent Pharma Inc. is recalling 6,000 bottles of Guaifenesin DAC Oral Solution, Sugar free, 100 mg/30 mg/10 mg per 5 mL. The affected product is identified by NDC 16571-301-16 and includes Lot #17E031 (Exp. 05/2019) and Lot #18F030 (Exp. 06/2020). The product was manufactured by Bio-Pharm Inc. and distributed by Rising Pharmaceuticals Inc.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations that resulted in potential product contamination with Burkholderia cepacia and Ralstonia pickettii. The agency has classified this recall as Class II.
The product was distributed to 9 distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States. Consumers should check their medication for the specific lot numbers and expiration dates listed above and discontinue use if they match the recalled product.
The recalled product
- Product
- Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codeine Phosphate Oral Solution, USP), Expectorant, Nasal Decongestant, Cough Suppressant, 100 mg/30 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-301-16, Manufactured by Bio-Pharm Inc.…
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 6,000
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 (4)
- Lot #s: 17E031
- Exp. 05/2019
- 18F030
- Exp. 06/2020.
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 →Related recalls
Same manufacturer · Torrent Pharma Inc
See all →- HighFluoxetine Tablets USP 20 mg Recalled for N-Nitroso Contamination
FDA (Drugs) · 2025-06-11
- SevereFluoxetine Tablets 20 mg Recalled for N-Nitroso Impurity
FDA (Drugs) · 2025-06-11
- High
- ModerateCarbamazepine tablets recalled for failed dissolution specifications
FDA (Drugs) · 2022-01-19
- ModerateTelmisartan and Hydrochlorothiazide Tablets Recalled for Superpotency
FDA (Drugs) · 2021-12-22
Same hazard · bacterial contamination
See all →- HighClorox Recalls Scented Mistolin and Lestoil Cleaners in Puerto Rico
CPSC · 2026-09-03
- HighCurry chicken salad flagged for possible Listeria contamination in two states
USDA FSIS · 2026-07-30
- ModerateMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- SevereSurgical Convenience Kit Recalled for Bacterial Contaminant in Alcohol Prep Pads
FDA (Devices) · 2026-07-08
Similar recalls
- SeverePreferred Pharmaceuticals Recalls Robafen DM Due to Potential Bacterial Contamination
FDA (Drugs) · 2019-06-26
- SevereWoodfield Recalls Codeine-Guaifenesin Oral Solution Due to Potential Bacterial Contamination
FDA (Drugs) · 2018-01-17
- SevereDiphenhydramine Liquid Recalled for Potential Microbial Contamination
FDA (Drugs) · 2019-07-03
- SevereAcetaminophen Children's Liquid Recalled for Microbial Contamination Risk
FDA (Drugs) · 2019-07-03
- SevereTorrent Pharma Recalls Losartan Potassium Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-27
- SevereTorrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity
FDA (Drugs) · 2019-02-27