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.
3,222 recalls
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Class II Ongoing
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Reason: Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Lots, distribution and details
- Lots / codes
- Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
- Distribution
- USA Nationwide
- Quantity
- 187,656 containers
- Recall started
- June 16, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0491-2025
-
Class II Ongoing
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- 24PU06037, 24PU06038, 24PU06040, 24PU06041, 24PU06042, 24PU06043, 24PU06044, 24PU06045, 24PU0646, 24PU06047, 24PU06048, 24PU06049, 24PU06050, 24PU06052, 24PU06053, 24PU06054 & 24PU06055, Exp Date 11/30/2025; 24SU06001, 24SU06002, 24SU06003, 24SU06004, 24SU06005, 24SU06006, 24SU06007, 24SU06009, 24SU06010, 24SU06011 24SU06012, 24SU06013, 24SU06014, 24SU06015, 24SU06016, 24SU06017, 24SU06018, 24SU06019, 24SU06020, 24SU06021, 24SU06022, 24SU06023, 24SU06024, 24SU06025,24SU06026, 24SU06028,24SU06029, 24SU06030, 24SU06031, 24SU06032, 24SU06033 24SU06034, 24SU06035, 24SU06036, 24SU06037, 24SU06038, 24SU06039, 24SU06040, 24SU06041, 24SU06042, 24SU06043, 24SU06044, 24SU06045, 24SU06046, 24SU06047, 24SU06048, 24SU06049, 24SU06050, 24SU06051, 24SU06052, 24SU06053, 24SU06054, 24SU06055, 24SU06056, & 24SU06057, Exp Date 12/31/25 25AU06001, 25AU06002, 25AU06003. 25AU06004, 25AU06005, 25AU06006, 25AU06007, 25AU06008, 25AU06009, 25AU06010, 25AU06011, 25AU06013, 25AU06017, 25AU06020 25AU06021, 25AU06022, 25AU06027, 25AU06028, 25AU06029, 25AU06030, 25AU06031 25AU06032, 25AU06034, 25AU06035, 25AU06036, 25AU06037, 25AU06038, 25AU06039 25AU06040, 25AU06041, 25AU06042, 25AU06043, 25AU06044, 25AU06045, 25AU06046 25AU06047, 25AU06048, 25AU06049, 25AU06050, 25AU06051, 25AU06052, 25AU06053 & 25AU06056, Exp Date 1/31/26 25BU06001, 25BU06003, 25BU06004, 25BU06005, 25BU06006, 25BU06007, 25BU06008 25BU06009, 25BU06010, 25BU06011, 25BU06018, 25BU06020, 25BU06023, 25BU06024 25BU06026, 25BU06027, 25BU06028, 25BU06030, 25BU06031, 25BU06032, 25BU06033 25BU06034, 25BU06035, 25BU06036, 25BU06037, 25BU06038, 25BU06039, 25BU06040 25BU06041, 25BU06042, 25BU06043, 25BU06044, 25BU06045, 25BU06046 25BU06047, 25BU06049, 25BU06050, 25BU06051, 25BU06053 & 25BU06054, Exp Date 02/28/26 25CU06002, 25CU06003, 25CU06004, 25CU06005, 25CU06006, 25CU06007, 25CU06008 25CU06012, 25CU06013, 25CU06015, 25CU06016, 25CU06020, 25CU06021, 25CU06022 25CU06023, 25CU06024, 25CU06026, 25CU06028, 25CU06030, 25CU06032, 25CU06035 25CU06039, Exp Date 03/31/2026
- Distribution
- Nationwide.
- Quantity
- 3,651,468 containers
- Recall started
- May 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0490-2025
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Class II Ongoing
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC…
Reason: Discoloration; discolored solution from cracked vials
Lots, distribution and details
- Product
- DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC Carton: 0409-2344-02; NDC Vial: 0409-2344-62
- Lots / codes
- Lot KA5023, exp 02/28/2026
- Distribution
- Nationwide in the USA
- Quantity
- 98,410 vials
- Recall started
- May 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0489-2025
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Class II Ongoing
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: GA37484
- Distribution
- USA Nationwide
- Quantity
- 16 syringes
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0487-2025
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Class II Ongoing
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: C03125A
- Distribution
- USA Nationwide
- Quantity
- 242 syringes
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0486-2025
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Class II Ongoing
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: C03065F
- Distribution
- USA Nationwide
- Quantity
- 216 syringes
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0485-2025
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Class II Ongoing
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: H388348
- Distribution
- USA Nationwide
- Quantity
- 4 syringes
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0484-2025
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Class II Ongoing
Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #BH11235 exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; BH272962 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; BH272962 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; BH00048 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRO30625-2 , exp 9/2/2025 ; PRO30625-2 , exp 9/2/2025 ; PRO30625-2 , exp 9/2/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ;
- Distribution
- USA Nationwide
- Quantity
- 826 syringes
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0483-2025
-
Class II Ongoing
Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot, expiry: H272962, exp 12/5/2025; S5045185, exp 5/20/2025; H272962, exp 12/5/2025; H270625, exp 9/30/2025
- Distribution
- USA Nationwide
- Quantity
- 24 syringes
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0482-2025
-
Class II Ongoing
Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: C03075J, Ex p 7/7/2025
- Distribution
- USA Nationwide
- Quantity
- 28 syringes
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0481-2025
-
Class II Ongoing
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: C03035J, Exp 7/3/2025, H202959, exp 7/6/2025; AB20N110720 , exp 7/7/2025 ; AB60N1121, exp 7/7/2025; PRX022225-1 , exp 8/24/2025 ; U122024 , exp 10/26/2025
- Distribution
- USA Nationwide
- Quantity
- 164 syringes
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0480-2025
-
Class II Ongoing
Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: H270221, Exp 12/26/2025
- Distribution
- USA Nationwide
- Quantity
- 32 syringes
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0479-2025
-
Class II Ongoing
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: O-O8A01-25, Exp 3/7/2025
- Distribution
- USA Nationwide
- Quantity
- 16 syringes
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0478-2025
-
Class II Ongoing
LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, and Lidocaine 1 mg in…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, and Lidocaine 1 mg in SWFI), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- Lots / codes
- Lot #: H227226, Exp 12/24/2025; H360175, Exp 6/2/2025; H368308, Exp 6/2/2025; Lot S360175, Exp 6/2/2025
- Distribution
- USA Nationwide
- Quantity
- 102 syringes
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0477-2025
-
Class II Ongoing
LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewoo…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- Lots / codes
- Lot #: H277639, Exp 6/25/2025
- Distribution
- USA Nationwide
- Quantity
- 64 syringes
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0476-2025
-
Class II Ongoing
CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot#: H261968, Exp 12/23/2025; H261358, Exp 5/13/2025
- Distribution
- USA Nationwide
- Quantity
- 60 syringes
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0475-2025
-
Class II Ongoing
Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: H228307, Exp 12/27/2025
- Distribution
- USA Nationwide
- Quantity
- 5
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0474-2025
-
Class II Ongoing
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01.
Reason: Presence of foreign tablets/capsules.
Lots, distribution and details
- Lots / codes
- Lot#: 5420094, Exp 09/30/2027
- Distribution
- USA Nationwide
- Quantity
- 36612 cartons
- Recall started
- May 23, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0473-2025
-
Class I Completed
UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134
Reason: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Lots, distribution and details
- Lots / codes
- All Lots; All Expiration Dates.
- Distribution
- U.S. Nationwide via internet.
- Quantity
- 1,704 30-count bottles
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0493-2025
-
Class I Completed
UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295
Reason: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
Lots, distribution and details
- Lots / codes
- All Lots; All Expiration Dates.
- Distribution
- U.S. Nationwide via internet.
- Quantity
- 1,342 30-count bottles
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0492-2025
-
Class II Ongoing
Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25
Reason: Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Lots, distribution and details
- Lots / codes
- Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
- Distribution
- Nationwide in the USA
- Quantity
- 48,000 vials
- Recall started
- May 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0472-2025
-
Class II Ongoing
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
Reason: cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Lots, distribution and details
- Lots / codes
- Lot#: AEF124004A, Exp date 08/31/2026
- Distribution
- USA Nationwide.
- Quantity
- 4,608 bottles
- Recall started
- May 22, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0471-2025
-
Class II Completed
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.
Reason: Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Lots, distribution and details
- Lots / codes
- Lot #s: B237040, B237041, Exp 10/31/2025
- Distribution
- IL, PA, & MS
- Quantity
- 11,616 bottles
- Recall started
- May 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0497-2025
-
Class I Ongoing
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral S…
Reason: Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Lots, distribution and details
- Product
- Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
- Lots / codes
- Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
- Distribution
- Nationwide in the USA
- Quantity
- 6396 bottles
- Recall started
- June 2, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0488-2025
-
Class III Ongoing
Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India,…
Reason: Presence of a foreign substance: black hair found embedded in tablet.
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.
- Lots / codes
- Lot #: MLF2401A, Exp 01/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 1,344- 1000 count bottles
- Recall started
- May 29, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0470-2025
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 November 2, 2026 14:41. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.