Class IIMedicationMar 20, 2026
Fagron Compounding Services: Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Product, lots & distribution
Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01 — Distribution: Nationwide in the U.S.A. — Lots/codes: Lot: C274-000050857, Exp.:7/6/2026; C274-000049316, Exp.: 4/26/2026; C274-000049367, Exp.: 4/28/2026; C274-000049496, Exp.: 5/3/2026; C274-000049518, Exp.: 5/4/2026; C274-000049535, Exp.: 5/5/2026; C274-000049653, Exp.: 5/11/2026; C274-000049654, Exp.: 5/11/2026; C274-000049745, Exp.: 5/16/2026; C274-000050128, Exp.: 5/31/2026; C274-000050151, Exp.: 6/1/2026; C274-000050184, Exp.: 6/6/2026; C274-000050504, Exp.: 6/15/2026; C274-000050662, Exp.: 6/21/2026; C274-000050836, Exp.: 7/5/2026; C274-000051014, Exp.: 7/13/2026; C274-000051057, Exp.: 7/18/2026; C274-000051240, Exp.: 7/25/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Fagron Compounding Services: Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Product, lots & distribution
Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01 — Distribution: Nationwide in the U.S.A. — Lots/codes: Lot: C274-000050858, Exp.:7/6/2026; C274-000051018, Exp.: 7/13/2026; C274-000049194, Exp.: 4/20/2026; C274-000049591, Exp.: 5/9/2026; C274-000049592, Exp.: 5/9/2026; C274-000049823, Exp.: 5/18/2026; C274-000050301, Exp.: 6/8/2026; C274-000050411, Exp.: 6/13/2026; C274-000051056, Exp.:7/18/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Fagron Compounding Services: Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Product, lots & distribution
Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01 — Distribution: Nationwide in the U.S.A. — Lots/codes: Lot: C274-000050987, Exp.:7/12/2026; C274-000049425, Exp.: 5/2/2026; C274-000050069, Exp.: 5/30/2026; C274-000050346, Exp.: 6/10/2026; C274-000050698, Exp.: 6/27/2026; C274-000050699, Exp.:6/27/2026; C274-000050775, Exp.:7/4/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured for Your Military Exchanges By:…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Product, lots & distribution
exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC., 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC 83698-580-30, UPC: 614299398870. — Distribution: US Nationwide. — Lots/codes: Lot # 20241030, Exp Date: 10/30/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for Your Military Exchanges By: Med…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Product, lots & distribution
exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC: 83698-581-30, UPC: 614299398887. — Distribution: US Nationwide. — Lots/codes: Lot # 20241030, Exp Date: 10/30/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473 Blair Rd, Suite 100, PMB…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Product, lots & distribution
caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473 Blair Rd, Suite 100, PMB 24308, Dallas TX 75231, Made in China, NDC: 83698-421-90, UPC: 810025928407. — Distribution: US Nationwide. — Lots/codes: Lot # 20241030, Exp Date: 10/30/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey Lemon, 30-count bag, Distributed By: Drug Mart-Food Fair, Medi…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Product, lots & distribution
Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey Lemon, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio, 44256, Made in China, NDC: 83698-150-30, UPC: 093351037092. — Distribution: US Nationwide. — Lots/codes: Lot # 20241030, Exp Date: 10/30/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio 4425…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Product, lots & distribution
Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio 44256, Made in China, NDC: 83698-102-30, UPC: 093351037085. — Distribution: US Nationwide. — Lots/codes: Lot # 20241030, Exp Date: 10/30/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC, 10…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Product, lots & distribution
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-125-25, UPC: 383173000085 — Distribution: US Nationwide. — Lots/codes: Lot# 20240524, Exp Date: 05/24/2026; Lot# 20240720, Exp Date: 07/20/2026; Lot# 20240730, Exp Date: 07/30/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier C…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Product, lots & distribution
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-30, UPC: 383173000047. — Distribution: US Nationwide. — Lots/codes: Lot# 20240524, Exp Date: 05/24/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier C…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Product, lots & distribution
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-80, UPC: 383173000030. — Distribution: US Nationwide. — Lots/codes: Lot# 20240730, Exp Date: 07/30/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Black Cherry Flavor, 25-count bag, Distributed By: CDMA, Inc., N…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Product, lots & distribution
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Black Cherry Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372. — Distribution: US Nationwide. — Lots/codes: Lot# 20240720, Exp Date: 07/20/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Product, lots & distribution
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372. — Distribution: US Nationwide. — Lots/codes: Lot # 20240524, Exp Date: 05/24/2026; Lot # 20240720, Exp Date: 07/20/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon Flavor, 25-count bag, Distributed By: CDMA, Inc., Nov…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Product, lots & distribution
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372. — Distribution: US Nationwide. — Lots/codes: Lot # 20240720, Exp Date: 07/20/2026, Lot # 20241030, Exp Date: 10/30/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Mad…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Product, lots & distribution
QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-625-30, UPC: 635515999398. — Distribution: US Nationwide. — Lots/codes: Lot # 20240720, Exp Date: 07/20/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375,…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Product, lots & distribution
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-617-30, UPC: 63551598673. — Distribution: US Nationwide. — Lots/codes: Lot # 20240720, Exp Date: 07/20/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Product, lots & distribution
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-675-30, UPC: 635515986718. — Distribution: US Nationwide. — Lots/codes: Lot # 20240720, Exp Date: 07/20/2026; Lot # 20240524, Exp Date: 05/24/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Product, lots & distribution
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-620-30, UPC: 635515999411. — Distribution: US Nationwide. — Lots/codes: Lot # 20240720, Exp Date: 07/20/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Leading Pharma, LLC: Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Product, lots & distribution
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01 — Distribution: US Nationwide. — Lots/codes: Lots# H03125, H03225, H03325, Exp Date: 2027/08 — Status: Ongoing (voluntary: firm initiated)
Class IIIFoodMar 20, 2026
Bee Well Honey Farm & Supply Inc.: Raw & Unfiltered Bee Well Wildflower Honey NET wT. 12 OZ (340g) UPC 8 32587 00003 2, NET WT. 22 OZ (624g) UPC 8 32587 00002 5 & NET WT. 44 OZ (1.25g) UPC 8 32587 00…
High sugar content. The firm was notified by the FDA that sample results were positive for a high C4 sugar content.
Product, lots & distribution
Raw & Unfiltered Bee Well Wildflower Honey NET wT. 12 OZ (340g) UPC 8 32587 00003 2, NET WT. 22 OZ (624g) UPC 8 32587 00002 5 & NET WT. 44 OZ (1.25g) UPC 8 32587 00001 8 100% Pure Honey Bee Well Honey 909 W. Main Street Pickens, SC 29671 — Distribution: Product was shipped to retailers in South Carolina. — Lots/codes: 7/24/29 — Status: Terminated (voluntary: firm initiated)
Class IIMedicationMar 19, 2026
Amneal Pharmaceuticals, LLC: traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal…
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
Product, lots & distribution
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5. — Distribution: Nationwide within the USA — Lots/codes: Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 19, 2026
Teva Pharmaceuticals USA, Inc: Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake…
CGMP Deviations: use of an unapproved raw material
Product, lots & distribution
Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3508-04 carton, NDC 0591-3508-54 pouch — Distribution: Within U.S — Lots/codes: Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 19, 2026
Teva Pharmaceuticals USA, Inc: Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake…
CGMP Deviations: use of an unapproved raw material
Product, lots & distribution
Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch — Distribution: Within U.S — Lots/codes: Lot: 100060002, Exp.: 07/2026; 100066802, Exp.: 05/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 19, 2026
Teva Pharmaceuticals USA, Inc: Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake…
CGMP Deviations: use of an unapproved raw material
Product, lots & distribution
Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3510-04 carton, NDC 0591-3510-54 pouch — Distribution: Within U.S — Lots/codes: Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMar 19, 2026
Riverence Provisions LLC: Riverence Smoked Trout Dip, net wt. 7oz. Product is perishable, refrigerated, packaged in plastic tub. Product is shipped to consignee frozen by the case (12/7oz. units per…
Label declares cream cheese but does not declare milk
Product, lots & distribution
Riverence Smoked Trout Dip, net wt. 7oz. Product is perishable, refrigerated, packaged in plastic tub. Product is shipped to consignee frozen by the case (12/7oz. units per case). Retail container UPC 7 07651 30561 3. Case item UPC #007076513057 Label declares Ingredients: Smoked Trout, Whipped Cream Cheese, Sour Cream, Horseradish, Lemon Juice, Dill, Black Pepper. Contains: Fish (Rainbow Trout). — Distribution: Distributed in CA, MA, NJ, NY, OR, TX, UT, VT. — Lots/codes: Lot #25339, 26037, and 26057. Best By Dates: 12/5/2026, 8/6/2027, and 8/27/2027 is marked on the side of the case. However, these best before dates are for the cases while the product is frozen. Once an individual unit is moved out of the case and into refrigeration the shelf life is 45-days. Therefore, the consumer of an individual unit will not see the best before dates associated with a case of frozen product. Direct consignees were instructed to add a best before date to an individual unit based on the date moved from a freezer to a refrigerator. — Status: Ongoing (voluntary: firm initiated)
Class IMedicationMar 18, 2026
Amneal Pharmaceuticals, LLC: Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals…
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Product, lots & distribution
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3. — Distribution: U.S.A. Nationwide — Lots/codes: Lot: AH250162, Exp 8/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationMar 18, 2026
Island Kinetics, Inc. d.b.a. CoValence Laboratories: Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
Subpotent Drug
Product, lots & distribution
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13 — Distribution: U.S. Nationwide — Lots/codes: Lot 4155D2, 4155D3; Exp. 05/15/2026 — Status: Terminated (voluntary: firm initiated)
Class IIIMedicationMar 18, 2026
Island Kinetics, Inc. d.b.a. CoValence Laboratories: Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Air…
Subpotent Drug
Product, lots & distribution
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04 — Distribution: U.S. Nationwide — Lots/codes: Lot 4212D2; Exp. 07/03/2026 — Status: Terminated (voluntary: firm initiated)
Class IIIMedicationMar 18, 2026
Island Kinetics, Inc. d.b.a. CoValence Laboratories: Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.…
Subpotent Drug
Product, lots & distribution
Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05 — Distribution: U.S. Nationwide — Lots/codes: Lot 4212D4; Exp. 07/31/2026 — Status: Terminated (voluntary: firm initiated)
Class IIMedicationMar 17, 2026
Chiesi USA, Inc.: CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Lack of Assurance of Sterility
Product, lots & distribution
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03. — Distribution: Nationwide within the United States — Lots/codes: Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 17, 2026
Teva Pharmaceuticals USA, Inc: Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen Interna…
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Product, lots & distribution
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08. — Distribution: Nationwide in the USA — Lots/codes: Lot: 4401619, Exp.: 09/30/2026; 4501005, 03/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 17, 2026
Teva Pharmaceuticals USA, Inc: Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen Interna…
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Product, lots & distribution
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08. — Distribution: Nationwide in the USA — Lots/codes: Lot: 4401491, 4401600, 4401603, 4401629, Exp.: 9/31/2026; 4500594, 4500786, 4500920, 4501007, 4501462, Exp.: 3/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 17, 2026
Teva Pharmaceuticals USA, Inc: Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen Interna…
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Product, lots & distribution
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9262-08. — Distribution: Nationwide in the USA — Lots/codes: Lot:4400401, Exp.: 6/30/2026; 4401393, 4401494, 4401604, Exp.: 9/31/2026; 4500564, 4500601, 4500707, 4500796, 4500859, 4500918, 4500919, 4501006, Exp.: 3/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 17, 2026
Viatris, Inc.: Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91
Failed Dissolution Specifications
Product, lots & distribution
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91 — Distribution: US Nationwide. — Lots/codes: Lot# 8177156, Exp Date: 02/28/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 17, 2026
Nephron SC, LLC: Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Colu…
Labelling: Illegible label
Product, lots & distribution
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05. — Distribution: Nationwide within the United States — Lots/codes: Lot AB6001, exp date 1/15/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 16, 2026
Amerisource Health Services LLC: Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: Ame…
Failed tablet specifications.
Product, lots & distribution
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217. — Distribution: U.S. Nationwide — Lots/codes: Lot #1024852; Exp 9/30/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 16, 2026
Cipla USA, Inc.: Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boul…
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Product, lots & distribution
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02 — Distribution: Nationwide in the USA — Lots/codes: Lot, expiry: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026; Lot 5PB0173, exp January-2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 16, 2026
Cipla USA, Inc.: Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boul…
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Product, lots & distribution
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02 — Distribution: Nationwide in the USA — Lots/codes: Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 16, 2026
Cipla USA, Inc.: Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boul…
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Product, lots & distribution
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02 — Distribution: Nationwide in the USA — Lots/codes: Lot, expiry: 4PB0224, exp March-2026; 4PB0505, 4PB0506, 4PB0507, exp September-2026; 5PB0564, exp April-2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMar 16, 2026
Albertsons Companies LLC: Lucerne 2% Cottage Cheese 2% Milkfat Small Curd Vitamin A Added Grade A. Net wt.24oz. Perishable and keep refrigerated. Consumer package is a plastic cup with foil lid and c…
Metal fragments. The potential foreign object is a hard, metal (stainless steel), curled spring. Dimensions of a similar spring measure 2.27mm in cross-sectional thickness and 25.38mm in coil width. Spring ends are not sharp but may be sharp if broken/ cut.
Product, lots & distribution
Lucerne 2% Cottage Cheese 2% Milkfat Small Curd Vitamin A Added Grade A. Net wt.24oz. Perishable and keep refrigerated. Consumer package is a plastic cup with foil lid and clear plastic lid. UPC 0 21130 07662 8. Distributed by Lucerne Foods, Inc PO Box 99, Pleasanton, CA. Product is distributed in a 6-pack case that consists of a flat cardboard tray and clear plastic film. There are no graphics on the distribution unit. The cases are broken down and product is merchandised as a single 24 oz. — Distribution: Distributed in AK, ID, CA, OR, and WA. — Lots/codes: BEST BEFORE MAR 31 2026. — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMar 16, 2026
Pocas International Corp.: POPPING BOBA RTD PEACH OOLONG TEA 12 X 13.8OZ
Packaging integrity issue that may compromise product quality .
Product, lots & distribution
POPPING BOBA RTD PEACH OOLONG TEA 12 X 13.8OZ — Distribution: The product was distributed to the following states: NY, VA, FL, MA, TX, LA, UT, CA and Canada — Lots/codes: Will be provided by firm — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMar 16, 2026
Pocas International Corp.: POPPING BOBA RTD MIXED BERRY HIBISCUS TEA 12 X 13.8OZ
Packaging integrity issue that may compromise product quality .
Product, lots & distribution
POPPING BOBA RTD MIXED BERRY HIBISCUS TEA 12 X 13.8OZ — Distribution: The product was distributed to the following states: NY, VA, FL, MA, TX, LA, UT, CA and Canada — Lots/codes: Will be provided by firm — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMar 16, 2026
Pocas International Corp.: POPPING BOBA RTD STRAWBERRY DRAGON F/OOLONG TEA 12 X 13.8OZ
Packaging integrity issue that may compromise product quality .
Product, lots & distribution
POPPING BOBA RTD STRAWBERRY DRAGON F/OOLONG TEA 12 X 13.8OZ — Distribution: The product was distributed to the following states: NY, VA, FL, MA, TX, LA, UT, CA and Canada — Lots/codes: Will be provided by firm — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMar 16, 2026
Pocas International Corp.: POPPING BOBA RTD MANGO PASSION FRUIT GREEN TEA 12 X 13.8OZ
Packaging integrity issue that may compromise product quality .
Product, lots & distribution
POPPING BOBA RTD MANGO PASSION FRUIT GREEN TEA 12 X 13.8OZ — Distribution: The product was distributed to the following states: NY, VA, FL, MA, TX, LA, UT, CA and Canada — Lots/codes: Will be provided by firm — Status: Terminated (voluntary: firm initiated)
Class IIMedicationMar 13, 2026
Cipla USA, Inc.: Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greec…
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Product, lots & distribution
Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67 — Distribution: Nationwide in the USA — Lots/codes: Lot, expiry: 4401666IR1, Exp 8/31/2027; 4401703IR1, Exp 9/30/2027; 4401703IR2, EXP 9/30/2027; 4401704IR1, Exp 9/30/2027; 4401705IR1, Exp 9/30/2027; 4401706IR1, Exp 9/30/2027; 4401720IR1, Exp 9/30/2027; 4401721IR1, Exp 9/30/2027; 4401733IR1, Exp 9/30/2027; 4401770IR1, Exp 9/30/2027; 4401777IR1, Exp 9/30/2027; 4401788IR1, Exp 10/31/2027; 4401804IR1, Exp 10/31/2027; 4401805IR1, Exp 10/31/2027; 4401824IR1, Exp 10/31/2027; 4401860IR1, Exp 10/31/2027; 4500019IR1, Exp 11/30/2027; 4500035IR1, Exp 11/30/2027; 4500036IR1, Exp 11/30/2027; 4500078IR1, Exp 11/30/2027; 4500079IR1, Exp 11/30/2027; 4500102IR… — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 13, 2026
Cipla USA, Inc.: Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for:…
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Product, lots & distribution
Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC 69097-906-67 — Distribution: Nationwide in the USA — Lots/codes: Lot, expiry: 4401699IR1, Exp. 5/31/2026; 4401699IR2, Exp. 5/31/2026; 4401700IR1, Exp. 5/31/2026; 4401701IR1, Exp. 5/31/2026; 4401702IR1, Exp. 5/31/2026; 4401722IR1, Exp. 5/31/2026; 4401723IR1, Exp. 5/31/2026; 4401724IR1, Exp. 5/31/2026; 4401725IR1, Exp. 5/31/2026; 4401732IR1, Exp. 5/31/2026; 4401768IR1, Exp. 6/30/2026 4401769IR1, Exp. 11/30/2026; 4401787IR1, Exp. 11/30/2026; 4401815IR1, Exp. 11/30/2026; 4401816IR1, Exp. 11/30/2026; 4401834IR1, Exp. 11/30/2026; 4401835IR1, Exp. 11/30/2026; 4401846IR1, Exp. 11/30/2026; 4401851IR1, Exp. 11/30/2026; 4500017IR1, Exp. 12/31/2026; 4500031IR1, Exp. 1… — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 13, 2026
ENDO USA, Inc.: Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Crystallization; identified as Buprenorphine free base
Product, lots & distribution
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05. — Distribution: USA Nationwide — Lots/codes: Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IFoodMar 13, 2026
Pure Vitamins and Natural Supplements, LLC: Boner Bears Honey Male Enhancement 100% Wildflower Honey, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume 1 entire pouch 30 minutes be…
FDA analysis revealed the presence of undeclared sildenafil and Tadalafil
Product, lots & distribution
Boner Bears Honey Male Enhancement 100% Wildflower Honey, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume 1 entire pouch 30 minutes before Intercourse. MANUFACTURED IN: FLORIDA. UPC 788362191603 — Distribution: New Jersey — Lots/codes: Lot # BBH0128 EXP 01/28 — Status: Ongoing (voluntary: firm initiated)
Class IFoodMar 13, 2026
Pure Vitamins and Natural Supplements, LLC: Blue Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume Entire Pouch 30 Minutes before Intercou…
FDA analysis revealed the presence of undeclared sildenafil
Product, lots & distribution
Blue Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume Entire Pouch 30 Minutes before Intercourse. Produced by Blue Bull Corporation Made In USA. UPC Code 707443349917 — Distribution: New Jersey — Lots/codes: EXP Date 02/2029 — Status: Ongoing (voluntary: firm initiated)
Class IFoodMar 13, 2026
Pure Vitamins and Natural Supplements, LLC: Red Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume Entire Pouch 30 Minutes before Intercour…
FDA analysis revealed the presence of undeclared sildenafil
Product, lots & distribution
Red Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume Entire Pouch 30 Minutes before Intercourse. Produced by Red Bull Corporation. Turkey www.redbullhoney.com UPC Code 9554100205595 — Distribution: New Jersey — Lots/codes: B/N ORB524 MFG Date: MAY 2024 EXP DATE: MAY 2029 — Status: Ongoing (voluntary: firm initiated)