Pedia Relief Cough-Cold Solution (Torrent Pharma) – Potential Contamination (2019)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough suppressant, nasal decongestant, Chlorpheniramine Maleate, USP 2 mg; Dextromethorphan HBr, USP 10 mg; Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10 mL)), 4 Fl. oz. (118 mL) bottle, NDC:0904-5050-20, Distributed by Major Pharmaceuticals, Livonia MI 48152.
Brand
Torrent Pharma Inc
Lot Codes / Batch Numbers
Lot #s: 17L020, Exp. 11/2019, 18C025, Exp. 03/2020, 18J020, Exp. 09/2020.
Products Sold
Lot #s: 17L020, Exp. 11/2019; 18C025, Exp. 03/2020; 18J020, Exp. 09/2020.
Torrent Pharma Inc is recalling Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough suppressant, nasal deconge due to cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026