FDA Recall
Ongoing
2026 recordClass II
norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02
by Fagron Compounding Services
- Reason
- Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
- Published
- April 15, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- April 15, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50.
by Fresenius Kabi USA, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- April 15, 2026
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- April 15, 2026
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- April 15, 2026
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- April 15, 2026
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- April 15, 2026
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- April 15, 2026
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- April 15, 2026
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- April 15, 2026
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- April 15, 2026
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- April 15, 2026
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- April 15, 2026
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- April 15, 2026
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- April 15, 2026
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- April 15, 2026
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- April 15, 2026
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- April 8, 2026
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- April 8, 2026
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- April 8, 2026
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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