Cough Syrup — Class II drug recall D-1368-2019
Terminated recall by Torrent Pharma Inc, reported 2019-06-19, distributed nationwide. cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii
| Recall number | D-1368-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Torrent Pharma Inc, Levittown, PA, United States |
| Recall initiated | 2019-05-21 |
| Classified | 2019-06-13 |
| Reported by FDA | 2019-06-19 |
| Terminated | 2020-10-06 |
| Distributed | Nationwide (US) |
| Quantity | 249,744 bottles |
| Reason classes | cgmp |
| Pathogens | burkholderia |
| NDC | 00536-0825-85 |
| Lot numbers | 17F022, 17G027, 17H021, 17H021A, 17J008, 17L001, 17M015, 18A018, 18B003, 18B008, 18C012, 18D005, 18F008, 18F043, 18G025, 18H004, 18H007, 18H016 |
| Expiration dates | 2019-06, 2019-07, 2019-08, 2019-09, 2019-11, 2019-12, 2020-01, 2020-02, 2020-03, 2020-04, 2020-06, 2020-07, 2020-08 |
Product
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.
Reason for recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1368-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.