Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
311 recalls
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Class II Ongoing
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
Reason: cGMP deviations.
Lots, distribution and details
- Lots / codes
- Lot 020226202150202, Exp Date 05/05/2026.
- Distribution
- U.S. Nationwide.
- Quantity
- 50 syringes
- Recall started
- April 1, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0508-2026
-
Class II Ongoing
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
Reason: cGMP deviations.
Lots, distribution and details
- Product
- fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
- Lots / codes
- Lot 022326203650432; Exp Date 06/25/2026
- Distribution
- U.S. Nationwide.
- Quantity
- 150 syringes
- Recall started
- April 1, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0506-2026
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Class II Ongoing
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
Reason: cGMP deviations.
Lots, distribution and details
- Lots / codes
- 120125202032701, Exp Date 04/01/2026; 122625202032857, Exp Date 04/25/2026; 122625202032862, Exp Date 04/28/2026, 122625202032863. Exp Date 04/28/2026; 122625202032864, Exp Date 04/28/2026; 122625202032865, Exp Date 04/28/2026, 011226202030062, Exp Date 05/14/2026, 011326202030776, Exp Date 05/15/2026; 011326202030077, Exp Date 05/15/2026, 011626202030111, Exp Date 05/20/2026, 011926202030122, Exp Date 05/21/2026; 011926202030123, Exp Date 05/21/2026, 012726202030159, Exp Date 05/28/2026, 020226202030200, Exp Date 06/04/2026, 020326202030216, Exp Date 06/05/2026, 020426202030234, Exp Date 06/06/2026, 02182202030398, Exp Date 06/20/2026.
- Distribution
- U.S. Nationwide.
- Quantity
- 2940 IV Bags
- Recall started
- April 1, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0504-2026
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Class II Ongoing
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Lots, distribution and details
- Lots / codes
- Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028.
- Distribution
- US Nationwide.
- Quantity
- 124,244 bags
- Recall started
- April 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0497-2026
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Class II Ongoing
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, M…
Reason: Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Lots, distribution and details
- Product
- Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10
- Lots / codes
- Batch # FD253967, Exp Date: 06/26/2027
- Distribution
- Nationwide in the USA.
- Quantity
- 4,740 1,000-count bottles.
- Recall started
- March 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0484-2026
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Class II Ongoing
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-151…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.
- Lots / codes
- All lots within expiry
- Distribution
- USA Nationwide.
- Quantity
- 7,120,750 ampules
- Recall started
- April 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0531-2026
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Class II Ongoing
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
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Lots, distribution and details
- 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.
- Distribution
- Nationwide in the U.S.A.
- Quantity
- 11,680 bags
- Recall started
- March 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0442-2026
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Class II Ongoing
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
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Lots, distribution and details
- 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.
- Distribution
- Nationwide in the U.S.A.
- Quantity
- 16,130 bags
- Recall started
- March 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0441-2026
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Class II Ongoing
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
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Lots, distribution and details
- 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.
- Distribution
- Nationwide in the U.S.A.
- Quantity
- 34,260 bags
- Recall started
- March 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0440-2026
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Class II Ongoing
norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Lots, distribution and details
- Lots / codes
- Lot: C274-000050004, Exp.: 4/24/2026; C274-000050295, Exp.:5/8/2026; C274-000050773, Exp.: 6/4/2026; C274-000051219, Exp.: 6/21/2026; C274-000051318, Exp.: 6/27/2026; C274-000051602, Exp.: 7/12/2026.
- Distribution
- Nationwide in the U.S.A.
- Quantity
- 5140 bags
- Recall started
- March 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0439-2026
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Class II Ongoing
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
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Lots, distribution and details
- Lots / codes
- Lot: C274-000049934, Exp.: 4/23/2026; C274-000049963, Exp.:4/24/2026; C274-000050074, Exp.: 4/30/2026; C274-000050123, Exp.:5/1/2026; C274-000050296, Exp.: 5/9/2026; C274-000050420, Exp.: 5/16/2026; C274-000050774, Exp.:6/5/2026; C274-000050924, 6/7/2026; C274-000050961, Exp.: 6/11/2026; C274-000050991, Exp.: 6/12/2026; C274-000051139, Exp.:6/19/2026; C274-000051166, Exp.:6/20/2026; C274-000051198, Exp.:6/21/2026; C274-000051343, Exp.:6/28/2026.
- Distribution
- Nationwide in the U.S.A.
- Quantity
- 25,260 bags
- Recall started
- March 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0438-2026
-
Class II Ongoing
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, Manufactu…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 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.
- Lots / codes
- Batch# 24EU10010, Exp Date: 05/31/2027.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0434-2026
-
Class II Ongoing
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, Manufa…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 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.
- Lots / codes
- Batch# 23SU10001, Exp Date: 12/31/2026; Batch# 24AU10003, 24AU10004, 24AU10005, 24AU10008, Exp Date: 01/31/2027; Batch # 24EU10001, 24EU10002, Exp Date: 05/31/2027; Batch# 24PU10002, Exp Date: 11/30/2027; Batch# 25BU10003, Exp Date: 02/29/2028; Batch# 25EU10005, Exp Date: 05/31/2028.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0433-2026
-
Class II Ongoing
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…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 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.
- Lots / codes
- Batch# 23DU10004, Exp Date: 04/30/2026; Batch# 23HU10006, Exp Date: 06/30/2026.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0432-2026
-
Class II Ongoing
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, Manufactur…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 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.
- Lots / codes
- Batch# 6402290, 6402291, Exp Date: 01/31/2028; Batch# 6402411, Exp Date: 02/29/2028; Batch# 6402412, 6402419, 6402424, 6402425, 6402426, 6402427, Exp Date: 03/31/2028; Batch# 6402479, 6402480, 6402517, 6402571, Exp Date: 05/31/2028; Batch# 6402518, Exp Date: 06/30/2028.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0431-2026
-
Class II Ongoing
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, Manuf…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 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.
- Lots / codes
- Batch# 6402153, Exp Date: 11/30/2026; Batch# 6402297, 6402298, Exp Date: 01/31/2027; Batch# 6402377, 6402378, 6402379, Exp Date: 02/28/2027; Batch # 6402429, 6402430, 6402431, 6402432, 6402433, Exp Date: 03/31/2027; Batch# 6402434, Exp Date: 04/30/2027; Batch# 6402512, Exp Date: 05/2027; Batch# 6402574, 6402576, Exp Date: 06/30/2027.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0430-2026
-
Class II Ongoing
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…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 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.
- Lots / codes
- Batch# 6402428, Exp Date: 10/31/2026; Batch# 6402481, 6402482, Exp Date: 11/30/2026.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0429-2026
-
Class II Ongoing
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…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 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.
- Lots / codes
- Batch# 24LU10013, 24LU10014, Exp Date: 09/30/2027; Batch# 24NU10001, 24NU10002, Exp Date: 10/31/2027.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0428-2026
-
Class II Ongoing
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…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 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.
- Lots / codes
- Batch# 23SU10008, Exp Date: 12/31/2026; Batch# 24JU10003, Exp Date: 07/31/2027; Batch# 24LU10011, 24LU10012, Exp Date: 9/30/2027; Batch# 6402273, 6402275, Exp Date: 01/31/2028; Batch# 6402420, 6402421, 6402422, 6402423, Exp Date: 03/31/2028; Batch# 6402473, 6402474, 6402475, 6402476, 6402485, Exp Date: 04/30/2028; Batch# 6402516, Exp Date: 05/31/2028.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0427-2026
-
Class II Ongoing
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, Uni…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 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.
- Lots / codes
- Batch# 6402299, 6402300, 6402301, 6402302, 6402303, Exp Date: 01/31/2027; Batch# 6402305, 6402398, Exp Date: 02/28/2027; Batch# 6402467, Exp Date: 04/30/2027; Batch# 6402577, 6402578, Exp Date: 06/30/2027.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0426-2026
-
Class II Ongoing
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: 65219-4…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 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.
- Lots / codes
- Batch# 6402372, 6402374, Exp Date: 08/31/2026; Batch# 6402437, Exp Date: 10/31/2026.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0425-2026
-
Class II Ongoing
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, Un…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 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).
- Lots / codes
- Batch # 6402413, Exp Date: 02/29/2028
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0424-2026
-
Class II Ongoing
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 333…
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44
- Lots / codes
- Lot 16240062A, exp date 3/2026
- Distribution
- Nationwide
- Quantity
- 1315 bottles
- Recall started
- February 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0403-2026
-
Class III Ongoing
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-…
Reason: Failed Tablet/Capsule Specifications
Lots, distribution and details
- Product
- Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35
- Lots / codes
- Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027
- Distribution
- Nationwide in the US, including Puerto Rico
- Quantity
- 2,699 blister cartons
- Recall started
- February 19, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0401-2026
-
Class II Ongoing
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10×10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 7006…
Reason: Failed Impurities/Degradation Specifications – OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Lots, distribution and details
- Product
- Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10×10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01
- Lots / codes
- Lot #: A240421, Exp 07/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 62190 vials
- Recall started
- February 4, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0398-2026
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.