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.
3 Class I (most serious) drug recalls reported in the last 30 days.
3,250 recalls
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Class II Ongoing
Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack
Reason: Crystallization
Lots, distribution and details
- Product
- Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack
- Lots / codes
- Lots T400514, Exp Date 02/2026 & T400808, Exp Date 03/2026
- Distribution
- US Nationwide
- Quantity
- 2760 packs
- Recall started
- December 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0172-2025
-
Class II Ongoing
Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack
Reason: Crystallization
Lots, distribution and details
- Product
- Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack
- Lots / codes
- Lots T400513, Exp Date 02/2026; T400807, Exp Date 03/2026; T401152, Exp Date 06/2026; T401303, Exp Date 07/2026; T401304, Exp Date 07/2026; T401399, Exp Date 07/2026 & T401696 Exp Date 08/2026.
- Distribution
- US Nationwide
- Quantity
- 23304 packs
- Recall started
- December 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0171-2025
-
Class I Ongoing
FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles
Reason: Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Lots, distribution and details
- Lots / codes
- All lots, Exp. Date: 03/27/2030
- Distribution
- Nationwide within the United States
- Quantity
- 374 bottles
- Recall started
- December 12, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0170-2025
-
Class III Terminated
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot #: A240211, Exp. Date April 2026
- Distribution
- Nationwide within the United States
- Quantity
- 5,870 bottles
- Recall started
- December 16, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0169-2025
-
Class II Ongoing
Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.
- Lots / codes
- Lot # 47101; Exp. 02/2026
- Distribution
- Nationwide USA
- Quantity
- 1016 50-count cartons
- Recall started
- December 4, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0168-2025
-
Class II Terminated
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 77…
Reason: Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03
- Lots / codes
- Lot# LA01276, Exp Date: 07/2026
- Distribution
- One US distributor in Ohio.
- Quantity
- 480 1000-count bottles
- Recall started
- December 20, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0167-2025
-
Class II Ongoing
UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323
Reason: cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.
Lots, distribution and details
- Lots / codes
- Lot#: 24183, Exp 07/01/28
- Distribution
- Product was sold via Amazon Marketplace.
- Quantity
- 321 bottles
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0166-2025
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Class II Ongoing
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged b…
Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Lots, distribution and details
- Product
- Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
- Lots / codes
- a) NDC 70518-0937-04, Lot # J0786744-061724, Exp. 06/30/2025 b) NDC 70518-0937-03, Lot # B3002625-060524, Exp. 10/31/2025
- Distribution
- Nationwide in the US
- Quantity
- a) 1,564 cards, b) 799 bottles
- Recall started
- December 2, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0165-2025
-
Class II Terminated
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate – 1 m…
Reason: Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Lots, distribution and details
- Product
- Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate – 1 mg; Stannous Chloride Dihydrate – 0.D75 mg; L-Cysteine Hydrochloride Monohydrate – 1 mg; Sodium Citrate Dihydrate – 2.6 mg; Mannitol – 20 mg. The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only, Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40
- Lots / codes
- Lot 092-24006, Catalog # N092D0, Exp 06/15/2026
- Distribution
- Nationwide USA and Canada.
- Quantity
- 5,160 vials (172 kits 30 vials/kit)
- Recall started
- November 26, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0164-2025
-
Class II Terminated
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
Reason: CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
Lots, distribution and details
- Lots / codes
- Lot # I24E77, A24E49, Exp Date: 04/30/25; J23C50, J23C97, L23B39, L23E98, Exp Date: 01/31/2025
- Distribution
- Distributed within US: FL, MS, WI
- Quantity
- 70, 90-count bottles
- Recall started
- December 4, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0163-2025
-
Class II Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berke…
Reason: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Lots, distribution and details
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
- Lots / codes
- Lot # 230077C, exp. date 11/2025
- Distribution
- Nationwide in the US
- Quantity
- 76,968 bottles
- Recall started
- December 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0162-2025
-
Class II Ongoing
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkel…
Reason: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Lots, distribution and details
- Product
- Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
- Lots / codes
- Lot # 222205C, exp. date 11/2025
- Distribution
- Nationwide in the US
- Quantity
- 163,883 bottles
- Recall started
- December 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0161-2025
-
Class II Completed
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01
Reason: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot#: 17230133, Exp 12/31/2024
- Distribution
- USA Nationwide
- Quantity
- —
- Recall started
- December 11, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0160-2025
-
Class II Completed
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
Reason: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot#: 17230132, Exp 12/2024; 17230449, Exp 01/2025
- Distribution
- USA Nationwide
- Quantity
- 3,888
- Recall started
- December 11, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0159-2025
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Class II Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Lots, distribution and details
- Lots / codes
- Lots, expiry: Lot DT6022166A, exp 11/30/2024; Lot DT6023071A, exp 2/28/2025
- Distribution
- Nationwide in the USA
- Quantity
- 1,815 bottles
- Recall started
- December 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0158-2025
-
Class II Ongoing
Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Lots, distribution and details
- Lots / codes
- Lot DT6023061B Exp 01/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 20,734 30-count bottles
- Recall started
- December 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0157-2025
-
Class II Ongoing
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Lots, distribution and details
- Lots / codes
- Lot DT3023030A Exp 2/28/2025
- Distribution
- Nationwide in the USA
- Quantity
- 13,678 bottles
- Recall started
- December 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0156-2025
-
Class II Ongoing
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Lots, distribution and details
- Lots / codes
- Lot DT3023029A Exp 02/28/2025
- Distribution
- Nationwide in the USA
- Quantity
- 21,262 bottles
- Recall started
- December 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0155-2025
-
Class II Ongoing
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmac…
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Product
- Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.
- Lots / codes
- Lot# BOB12318A Exp 07/31/2027
- Distribution
- Nationwide in the USA
- Quantity
- 15,744 30-count bottles
- Recall started
- November 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0154-2025
-
Class II Terminated
PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-003-01
Reason: Lack of Sterility Assurance
Lots, distribution and details
- Lots / codes
- Lot #: P120522A, Exp. Date 12/5/2025, P120522B, Exp. Date 12/5/2024; P120822A, Exp. Date 12/8/2024; P1208228, Exp. Date 12/8/2024; P121222A, P1212228, Exp. Date 12/12/2024; P121922A, P121922B, Exp. Date 12/19/2024; P122222A, Exp. Date 12/22/2024; P122622A, P122622B, Exp. Date 12/26/2024; P010223A, Exp. Date 1/2/2025; P010423PV1, Exp. Date 1/4/2025; P010523A, P010523B, Exp. Date 1/5/2025; P010923A, Exp. Date 1/9/2025; P011123PV2, Exp. Date 1/11/2025; P011223A, P011223B, Exp. Date 1/12/2025; P011623A, Exp. Date 1/16/2025; P011823PV3, Exp. Date 1/18/2025; P011923A, P011923B, Exp. Date 1/19/2025; P012323A, P012323B, Exp. Date 1/23/2025; P012623A, Exp. Date 1/26/2025; P013023A, Exp. Date 1/30/2025; P020123A, Exp. Date 2/1 /2025; P020723A, Exp. Date 2/7/2025; P021423, Exp. Date 2/14/2025, P021623A, Exp. Date 2/16/2025; P022023A, Exp. Date 2/20/2025; P022223A, Exp. Date 2/22/2025; P022823A, Exp. Date 2/28/2025; P030123A, Exp. Date 3/1/2025; P050423A, Exp. Date 5/4/2025, P051823A, Exp. Date 5/18/2025, P052523A, Exp. Date 5/25/2025
- Distribution
- Nationwide within the United States
- Quantity
- 59275
- Recall started
- December 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0153-2025
-
Class II Terminated
LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-006-01
Reason: Lack of Sterility Assurance
Lots, distribution and details
- Lots / codes
- Lot #: P121322A, P121322B, Exp. Date 12/13/2024; P121422A, Exp. Date 12/14/2024; P121922A, P121922B, Exp. Date 12/19/2024; P122022A, Exp. Date 12/20/2024; P122122A, P122122B, Exp. Date 12/21/2024; P122622A, P122622B, Exp. Date 12/26/2024; P122722A, P122722B, Exp. Date 12/27/2024; P122822A, P122822B, Exp. Date 12/28/2024. P010223A, Exp. Date 1/2/2025; P010323LV1, Exp. Date 1/3/2025; P010523A, P010523B, Exp. Date 1/5/2025; P010923A, Exp. Date 1/9/2025; P011023LV2, Exp. Date 1/10/2025, P011223A, P011223B, Exp. Date 1/12/2025; P011623A; Exp. Date 1/16/2025, P011723LV3, Exp. Date 1/17/2025; P011923A, P011923B, Exp. Date 1/19/2025; P012323A, P012323B, Exp. Date 1/23/2025; P012523A, Exp. Date 1/25/2025; P013123A, Exp. Date 1/31/2025; P020223A, Exp. Date 2/2/2025; P020623A, Exp. Date 2/6/2025,P020823A, Exp. Date 2/8/2025, P020923A, Exp. Date 2/9/2025, P021323A, Exp. Date 2/13/2025; P021523A, P021523B, Exp. Date 2/15/2025, P021623A, Exp. Date 2/16/2025, P022023A, Exp. Date 2/20/2025, P022123A, Exp. Date 2/21/2025, P022323A, Exp. Date 2/23/2025, P022723A, Exp. Date 2/27/2025, P030123A, Exp. Date 3/1/2025, P030223A, Exp. Date 3/2/2025, P030623A, Exp. Date 3/6/2025; P030723A, Exp. Date 3/7/2025; P030823A, Exp. Date 3/8/2025; P030923A Exp. Date 3/9/2025, P031423A, Exp. Date 3/14/2025, P032023A, Exp. Date 3/20/2025, P032123A, Exp. Date 3/21/2025; P032223A, Exp. Date 3/22/2025; P032723A, Exp. Date 3/27/2025; P040423A, Exp. Date 4/4/2025; P040523A, Exp. Date 4/5/2025; P040623A, Exp. Date 4/6/2025; P041023A, Exp. Date 4/10/2025;P041123A, Exp. Date 4/11/2025; P041223A, Exp. Date 4/12/2025; P041323A, Exp. Date 4/13/2025; P041723A, Exp. Date 4/17/2025; P041823A, Exp. Date 4/18/2025;P041923A, Exp. Date 4/19/2025; P042023A, Exp. Date 4/20/2025; P042423A, Exp. Date 4/24/2025; P042523A, Exp. Date 4/25/2025;P042623A, Exp. Date 4/26/2025; P050323A, Exp. Date 5/3/2025; P050823A, Exp. Date 5/8/2025;P050923A, Exp. Date 5/9/2025;P051023A, Exp. Date 5/10/2025;P051123A, Exp. Date 5/11/2025;P051523A, Exp. Date 5/15/2025; P051623A, Exp. Date 5/16/2025; P051723A, Exp. Date 5/17/2025; P052223A, Exp.: 5/22/2025; P052323A, Exp.: 5/23/2025; P052423A, Exp. Date 5/24/2025; P052523A, Exp.: 5/25/2025; P053023A, Exp. Date 5/30/2025; P053123A, Exp. Date 5/31/2025; P060123A, Exp. Date 6/1/2025; P060223A, Exp. Date 6/2/2025; P060523A, Exp. Date 6/5/2025; P060623A, Exp. Date 6/6/2025; P060723A, Exp. Date 6/7/2025; P060823A, Exp. Date 6/8/2025; P061223A, Exp. Date 6/12/2025; P061323A, Exp. Date 6/13/2025; P061423A, Exp. Date 6/14/2025
- Distribution
- Nationwide within the United States
- Quantity
- 170812 bottles
- Recall started
- December 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0152-2025
-
Class II Ongoing
VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp., Ronkonkoma, NY 11779, NDC 52925-512-10
Reason: CGMP deviations: out of specifications for assay
Lots, distribution and details
- Lots / codes
- Lot: 3A001/3A001A, Exp: 07/25
- Distribution
- Nationwide in the USA and 2 Distributors in Hong Kong
- Quantity
- 33,659 retail boxes in US
- Recall started
- November 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0151-2025
-
Class II Ongoing
Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05
Reason: Discoloration
Lots, distribution and details
- Lots / codes
- Lot #: F9026F01, F9026F02, Exp. Date 12/2025
- Distribution
- Nationwide within the United States
- Quantity
- 2160 packs/5 ampules per pack = 10,800 ampules
- Recall started
- November 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0150-2025
-
Class II Ongoing
Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30
Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Lots, distribution and details
- Product
- Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30
- Lots / codes
- Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027
- Distribution
- Nationwide in the USA
- Quantity
- —
- Recall started
- December 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0149-2025
-
Class II Terminated
Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only,
Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Lots, distribution and details
- Lots / codes
- Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-43619
- Distribution
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Quantity
- —
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0148-2025
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 3, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.