Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl, USP) Each teaspoonful contains diphenhydramine hydrochloride, USP 12.5 mg, a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-1228-00, b) One Pint (473 mL) bottle, NDC: 0904-5174-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.

Class I - Dangerous

💊 Drugs Recalled: May 21, 2019 Torrent Pharma Prescription Drugs

What Should You Do?

Check if you have this product:
Lot #s: a)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. b) 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; 18B010; 18B038, Exp. 02/2020; 18C008; 18C022; 18C030, Exp. 03/2020; 18D004; 18D008; 18D010; 18D011, Exp. 04/2020; 18F028; 18H010, Exp. 06/2020; 18G004; 18G012, Exp. 07/2020; 18H002; 18H011; 18H027; 18H032; 18H033, Exp. 08/2020; 18K008; 18K009, Exp. 10/2020.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Torrent Pharma Inc
Reason for Recall:: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl, USP) Each teaspoonful contains diphenhydramine hydrochloride, USP 12.5 mg, a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-1228-00, b) One Pint (473 mL) bottle, NDC: 0904-5174-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.

Product Codes/Lot Numbers:

Lot #s: a)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. b) 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; 18B010; 18B038, Exp. 02/2020; 18C008; 18C022; 18C030, Exp. 03/2020; 18D004; 18D008; 18D010; 18D011, Exp. 04/2020; 18F028; 18H010, Exp. 06/2020; 18G004; 18G012, Exp. 07/2020; 18H002; 18H011; 18H027; 18H032; 18H033, Exp. 08/2020; 18K008; 18K009, Exp. 10/2020.