Torrent Pharma Recalls Hyoscyamine Sulfate Elixir Due to Bacterial Contamination Risk
Torrent Pharma is recalling Hyoscyamine Sulfate Elixir 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, which corresponds to a Severe rating under the rubric for potential contamination with specific bacterial pathogens.
Plain-English summary
Torrent Pharma Inc is recalling 24,384 bottles of Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL (NDC:39328-048-16). The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations that resulted in potential product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii).
The affected product is a prescription-only liquid medication distributed in 473 mL (16 oz.) bottles. The recall covers specific lots with expiration dates ranging from June 2019 to July 2020, including lot numbers 17F021, 17G013, 17K010, 18E015, 18F029, 18F031, 18F042, and 18G024.
The product was distributed to nine distributors, direct accounts, and relabelers who may have further distributed the medication throughout the United States. Patients and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or distributor for disposal.
The recalled product
- Product
- Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle, NDC:39328-048-16, Patrin Pharma, Skokie IL 60076.
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Anticholinergic
- Hazard
- Affected units
- 24,384
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 (14)
- Lot #s: 17F021
- Exp. 06/2019
- 17G013
- Exp. 07/2019
- 17K010
- Exp. 10/2019
- 18E015
- Exp. 05/2020
- 18F029
- 18F031
- 18F042
- Exp. 06/2020
- 18G024
- Exp. 07/2020.
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
- SevereTorrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets
FDA (Drugs) · 2019-10-09
- SevereTorrent Pharma Recalls Losartan Potassium/Hydrochlorothiazide Tablets Due to Impurity
FDA (Drugs) · 2019-10-09
- SevereDiphenhydramine Liquid Recalled for Potential Microbial Contamination
FDA (Drugs) · 2019-07-03
- SevereTorrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity
FDA (Drugs) · 2019-04-17
- SevereAcetaminophen Children's Liquid Recalled for Microbial Contamination Risk
FDA (Drugs) · 2019-07-03
- SevereTorrent Pharma Recalls Losartan Potassium Tablets Due to Impurity
FDA (Drugs) · 2019-04-17