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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements

Torrent Pharma Inc: Various Medications Recalled for Potential Bacterial Contamination

Agency Publication Date: June 13, 2019
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Summary

Approximately 18,376,618 units of various liquid medications and suppositories, including products like RisperiDONE, Children's Acetaminophen, and Robafen cough syrups, are being recalled due to potential contamination with bacteria including Burkholderia cepacia and Ralstonia pickettii. The recall was initiated following deviations in manufacturing practices at the Bio-Pharm Inc. facility that could compromise product safety. These products were sold under various brands such as Major Pharmaceuticals, Rugby Laboratories, and Heritage Pharmaceuticals across the United States.

Risk

The affected products may be contaminated with bacteria that can cause serious infections, particularly in children, the elderly, or individuals with weakened immune systems. Contamination with Burkholderia cepacia and Ralstonia pickettii poses a significant health risk as these organisms can lead to respiratory or systemic infections that are difficult to treat.

What You Should Do

  1. Check your medicine cabinet for products from brands including Major Pharmaceuticals, Rugby Laboratories, Heritage Pharmaceuticals, Patrin Pharma, Rising Pharmaceuticals, and Torrent Pharma.
  2. Verify the specific product and lot numbers. For example, check RisperiDONE Oral Solution (NDC 13668-589-06) for lots 18F020, 18H013, 18J015, 18K015, 18K034, or 19A014; or Children's Mapap Acetaminophen (NDC 0904-1985-20) for any of the over 50 lots listed including 17E003, 18B030, and 18K014.
  3. Immediately stop using any medication identified as part of this recall.
  4. Contact your healthcare provider or pharmacist for guidance regarding alternative medications and to report any health concerns related to these products.
  5. Return any unused product to the pharmacy or place of purchase for a refund.
  6. Contact the manufacturer, Torrent Pharma Inc., for further instructions at their facility location in Levittown, Pennsylvania.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund for unused product

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: RisperiDONE Oral Solution, USP, 1 mg/mL (30 mL)
Model:
NDC 13668-589-06
Lot Numbers:
18F020 (Exp. 06/2020)
18H013 (Exp. 08/2020)
18J015 (Exp. 09/2020)
18K015 (Exp. 10/2020)
18K034 (Exp. 10/2020)
19A014 (Exp. 01/2021)
Product: Children's Acetaminophen Liquid, 160 mg per 5 mL (4 FL. oz.)
Model:
NDC: 59741-101-06
Lot Numbers:
17E035 (Exp. 05/2019)
Product: Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL (4 FL. oz.)
Model:
NDC: 59741-119-06
Lot Numbers:
17E019
17E045 (Exp. 05/2019)
Product: Children's Mapap Acetaminophen Liquid (4 FL. oz. or 1 Pint)
Model:
NDC 0904-1985-20
NDC 0904-1985-16
Lot Numbers (70):
17E003
17E038 (Exp. 05/2019)
17F002
17F005
17F007
17F025 (Exp. 06/2019)
17G014 (Exp. 07/2019)
17H015 (Exp. 08/2019)
17J004
17J006
17J016 (Exp. 09/2019)
17K008
17K013
17K021
17K027 (Exp. 10/2019)
17L021 (Exp. 11/2019)
17M032 (Exp. 12/2019)
18A023
18A039 (Exp. 01/2020)
18B007
18B030
18B037 (Exp. 02/2020)
18C017
18C026 (Exp. 03/2020)
18D003
18D034 (Exp. 04/2020)
18E027
18E033 (Exp. 05/2020)
18F024
18F033 (Exp. 06/2020)
18G001
18G023 (Exp. 07/2020)
18J008
18J009
18J017
18J027 (Exp. 09/2020)
18K013
18K014
18K028 (Exp. 10/2020)
17E006
17E008 (Exp. 05/2019)
17G001
17G008
17G025 (Exp. 07/2019)
17J022 (Exp. 09/2019)
17K001
17K007
17K007A (Exp. 10/2019)
17L014
17L034 (Exp. 11/2019)
Product: Robafen Cough Formula Expectorant (4 Fl. oz. or 1 Pint)
Model:
NDC: 0904-0061-00
NDC: 0904-0061-16
Lot Numbers:
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)
17G018 (Exp. 07/2019)
17H001
17H010
17H014 (Exp. 08/2019)
17J009 (Exp. 09/2019)
17K023 (Exp. 10/2019)
17L006
17L025 (Exp. 11/2019)
17M025
17M034 (Exp. 12/2019)
18A005
18A012
18A016 (Exp. 01/2020)
18B020 (Exp. 02/2020)
18C023
18C031 (Exp. 03/2020)
18E017 (Exp. 05/2020)
18G005
18G022 (Exp. 07/2020)
18H021
18H026 (Exp. 08/2020)
18J003 (Exp. 09/2020)
Product: Robafen AC Oral Solution (1 Pint)
Model:
NDC:0904-6479-16
Lot Numbers:
17M003 (Exp. 12/2019)
18A009
18A010 (Exp. 01/2020)
18B024 (Exp. 02/2020)
18F021 (Exp. 06/2020)
18G009
18G020 (Exp. 07/2020)
18K005
18K011 (Exp. 10/2020)
Product: Robafen DM Syrup (4 oz., 8 oz., or 16 oz.)
Model:
NDC: 0904-0053-00
NDC: 0904-0053-09
NDC:0904-0053-16
Lot Numbers:
17F001 (Exp. 06/2019)
17G016 (Exp. 07/2019)
17H017 (Exp. 08/2019)
17L002
17L024 (Exp. 11/2019)
17M010
17M013 (Exp. 12/2019)
18B006
18B031 (Exp. 02/2020)
18C033 (Exp. 03/2020)
18D015
18D016 (Exp. 04/2020)
18E020 (Exp. 05/2020)
18G013 (Exp. 07/2020)
18L010 (Exp. 11/2020)
19A010
19A019 (Exp. 01/2021)
17F015 (Exp. 06/2019)
17L009 (Exp. 11/2019)
17M012 (Exp. 12/2019)
18B015 (Exp. 02/2020)
18C034 (Exp. 03/2020)
18E026 (Exp. 05/2020)
18G011 (Exp. 08/2020)
17E014 (Exp. 05/2019)
17G009
17G020 (Exp. 07/2019)
17K019 (Exp. 10/2019)
17L012
17L013 (Exp. 11/2019)
17M016
17M033 (Exp. 12/2019)
18A002 (Exp. 01/2020)
18B009
18B019 (Exp. 02/2020)
18C015
18C035 (Exp. 03/2020)
18D001
18D002 (Exp. 04/2020)
18E018 (Exp. 05/2020)
18F027 (Exp. 06/2020)
18H017
18H018 (Exp. 08/2020)
18K016
18K035 (Exp. 10/2020)
Product: Banophen Oral Solution (4 Fl. oz. or 1 Pint)
Model:
NDC: 0904-1228-00
NDC: 0904-5174-16
Lot Numbers (70):
17E018
17E020
17E026 (Exp. 05/2019)
17H008
17H018
17H028 (Exp. 08/2019)
17J002
17J025
17J028 (Exp. 09/2019)
17L035 (Exp. 11/2019)
17M024 (Exp. 12/2019)
18A017 (Exp. 01/2020)
18B016 (Exp. 02/2020)
18C011 (Exp. 03/2020)
18D014
18D021
18D026 (Exp. 04/2020)
18E014 (Exp. 05/2020)
18F036 (Exp. 06/2020)
18F035
18G018 (Exp. 07/2020)
18H005
18H015 (Exp. 08/2020)
19A011
19A013 (Exp. 01/2121)
17E013
17E025
17E028
17E041 (Exp. 05/2019)
17F009
17F016 (Exp. 06/2019)
17G007
17G021
17G032 (Exp. 07/2019)
17H023 (Exp. 08/2019)
17J001
17J012
17J023
17J027 (Exp. 09/2019)
17K004
17K022
17K028
17K028A (Exp. 10/2019)
17L032 (Exp. 11/2019)
17M036 (Exp. 12/2019)
18A011
18A019
18A030
18A032
18A041 (Exp. 01/2020)
Product: Pseudoephedrine Oral Solution (1 Pint)
Model:
NDC: 0536-1850-85
Lot Numbers:
17H012 (Exp. 08/2019)
17L011 (Exp. 11/2019)
17M020 (Exp. 12/2019)
18D007 (Exp. 04/2020)
18J001 (Exp. 09/2020)
Product: Nasal Decongestant Spray Regular (0.5 FL. oz. or 1 FL. oz.)
Model:
NDC:0904-5711-35
NDC: 0904-5711-30
Lot Numbers:
17E032 (Exp. 05/2019)
17F011
17F020 (Exp. 06/2019)
17G003
17G011 (Exp. 07/2019)
17H016 (Exp. 08/2019)
17J005
17J017
17J026 (Exp. 09/2019)
17K029 (Exp. 10/2019)
17L027 (Exp. 11/2019)
18A003
18A004
18A033 (Exp. 01/2020)
18B011 (Exp. 02/2020)
18C029 (Exp. 03/2020)
18D019
18D025 (Exp. 04/2020)
18F014 (Exp. 06/2020)
18H029 (Exp. 08/2020)
18J007
18J018 (Exp. 09/2020)
18K007
18K026 (Exp. 10/2020)
19A012 (Exp. 01/2021)
17E011 (Exp. 05/2019)
17E012 (Exp. 06/2019)
17G019
17G023 (Exp. 07/2019)
17H011 (Exp. 08/2019)
17J029 (Exp. 09/2019)
17K005 (Exp. 10/2019)
17M005
17M018 (Exp. 12/2019)
18C001
18C004 (Exp. 03/2020)
18F032
18F019 (Exp. 06/2020)
Product: Biscolax Laxative (Bisacodyl, USP 10 mg) (12 or 100 suppositories)
Model:
NDC: 0904-5058-12
NDC: 0904-5058-60
Lot Numbers:
17E004
17E033 (Exp. 05/2019)
17F019 (Exp. 06/2019)
17G017 (Exp. 07/2019)
17K009
17K030 (Exp. 10/2019)
17M006
17M028 (Exp. 12/2019)
18A029 (Exp. 01/2020)
18C037 (Exp. 03/2020)
18E002 (Exp. 05/2020)
18F003
18F013 (Exp. 06/2020)
18G002
18G016 (Exp. 07/2020)
18H031 (Exp. 08/2020)
18J004 (Exp. 09/2020)
18L008
18L012 (Exp. 11/2020)
19A008 (Exp. 01/2021)
17E005
17E027 (Exp. 05/2019)
17K025 (Exp. 10/2019)
17M006 (Exp. 12/2019)
18A014 (Exp. 01/2020)
18B039 (Exp. 02/2020)
18C037 (Exp. 03/2020)
18D033 (Exp. 04/2020)
18E025 (Exp. 05/2020)
18F013
18F018 (Exp. 06/2020)
18G003 (Exp. 07/2020)
18H012
18H014 (Exp. 08/2020)
18J026 (Exp. 09/2020)
18L009 (Exp. 11/2020)
18M014 (Exp. 12/2020)
19A021 (Exp. 01/2021)
19B001
19B002 (Exp. 02/2021)
Product: Bisacodyl Suppositories, Brite Stock, Reese
Lot Numbers:
17J003 (Exp. 09/2019)
18A026 (Exp. 01/2020)
18E031 (Exp. 05/2020)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82889
Status: Resolved
Manufacturer: Torrent Pharma Inc
Sold By: Major Pharmaceuticals; Rugby Laboratories; Heritage Pharmaceuticals; Patrin Pharma; Rising Pharmaceuticals; distributors; relabelers
Manufactured In: United States
Units Affected: 40 products (48,955 bottles; 58,272 bottles; 118,080 bottles; 2,646,228 bottles; 984,888 bottles; 131,328 bottles; 1,500,672 bottles; 655,104 bottles; 1,436,904 bottles; 3,788,502 bottles; 262,008 bottles; 17,748 bottles; 391,404 cartons; 66,798 bottles; 53,520 bottles; 24,384 bottles; 361,260 bottles; 14,016 bottles; 233,388 bottles; 6,000 bottles; 148,440 bottles; 1,883,796 bottles; 66,060 bottles; 249,744 bottles; 176,580 bottles; 438,624 bottles; 62,748 bottles; 96,060 bottles; 153.540 bottles; 5,681 bottles; 264 bottles; 140,436 suppositories; 120,204 cartons; 82,872 bottles; 177,408 bottles; 1,126,404 bottles; 730,476 bottles; 52,368 bottles; 11,112 bottles; 7,728 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.