Drug Recall
Ongoing
2026 recordClass II
5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- March 11, 2026
- Reported by FDA
- April 15, 2026
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
View recall →
Drug Recall
Ongoing
2026 recordClass II
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- March 11, 2026
- Reported by FDA
- April 15, 2026
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
View recall →
Drug Recall
Ongoing
2026 recordClass II
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- March 11, 2026
- Reported by FDA
- April 15, 2026
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
View recall →
Drug Recall
Ongoing
2026 recordClass II
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- March 11, 2026
- Reported by FDA
- April 15, 2026
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
View recall →
Drug Recall
Ongoing
2026 recordClass II
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05.
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- March 11, 2026
- Reported by FDA
- April 15, 2026
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
View recall →
Drug Recall
Ongoing
2026 recordClass II
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- March 11, 2026
- Reported by FDA
- April 15, 2026
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
View recall →
Drug Recall
Ongoing
2026 recordClass II
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- March 11, 2026
- Reported by FDA
- April 15, 2026
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
View recall →
Drug Recall
Ongoing
2026 recordClass II
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- March 11, 2026
- Reported by FDA
- April 15, 2026
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
View recall →
Drug Recall
Ongoing
2026 recordClass II
0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30.
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- March 11, 2026
- Reported by FDA
- April 15, 2026
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
View recall →
Drug Recall
Ongoing
2026 recordClass II
0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50.
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- March 11, 2026
- Reported by FDA
- April 15, 2026
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
View recall →
Drug Recall
Ongoing
2026 recordClass II
0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- March 11, 2026
- Reported by FDA
- April 15, 2026
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
View recall →
Drug Recall
Ongoing
2026 recordClass II
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- March 11, 2026
- Reported by FDA
- April 15, 2026
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
View recall →
Drug Recall
Ongoing
2026 recordClass II
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
by Cipla USA, Inc.
- Reason
- Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
- Recall initiated
- March 13, 2026
- Reported by FDA
- April 15, 2026
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Ongoing
2026 recordClass II
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
by Cipla USA, Inc.
- Reason
- Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
- Recall initiated
- March 13, 2026
- Reported by FDA
- April 15, 2026
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Ongoing
2026 recordClass I
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.
by Amneal Pharmaceuticals, LLC
- Reason
- 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.
- Recall initiated
- March 18, 2026
- Reported by FDA
- April 8, 2026
- Distribution
- U.S.A. Nationwide
View recall →
Drug Recall
Ongoing
2026 recordClass II
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11.
by Appco Pharma LLC
- Reason
- cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
- Recall initiated
- March 27, 2026
- Reported by FDA
- April 8, 2026
- Distribution
- U.S.A. Nationwide
View recall →
Drug Recall
Ongoing
2026 recordClass II
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.
by Appco Pharma LLC
- Reason
- cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
- Recall initiated
- March 27, 2026
- Reported by FDA
- April 8, 2026
- Distribution
- U.S.A. Nationwide
View recall →
Drug Recall
Ongoing
2026 recordClass II
Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11.
by Appco Pharma LLC
- Reason
- cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
- Recall initiated
- March 27, 2026
- Reported by FDA
- April 8, 2026
- Distribution
- U.S.A. Nationwide
View recall →
Drug Recall
Ongoing
2026 recordClass II
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; b) Good Sense, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-110-01; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-006-05; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; e) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47008 3; f) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7; g) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; h) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14
by K.C. Pharmaceuticals, Inc
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- March 3, 2026
- Reported by FDA
- April 8, 2026
- Distribution
- Nationwide in the US
View recall →
Drug Recall
Ongoing
2026 recordClass II
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LUBRICATING EYE DROPS, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1219-94; b) Walgreens, Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20300 3
by K.C. Pharmaceuticals, Inc
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- March 3, 2026
- Reported by FDA
- April 8, 2026
- Distribution
- Nationwide in the US
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
