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
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 1…
Reason: Subpotent
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17
- Lots / codes
- Lot # D2300323, Exp Date: 01/2026
- Distribution
- Nationwide US.
- Quantity
- 4,888 Bottles
- Recall started
- April 10, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0394-2025
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Class II Ongoing
Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, D…
Reason: Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
Lots, distribution and details
- Product
- Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14.
- Lots / codes
- Lot PZFDE06, Exp 08/31/2025
- Distribution
- NC, SC, VA
- Quantity
- 48 Cartons
- Recall started
- April 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0393-2025
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Class II Ongoing
Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 – 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI…
Reason: Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
Lots, distribution and details
- Product
- Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 – 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave# 1507, CA 90501, NDC 71300-6564-1 (box), 71300-6564-3 (vial).
- Lots / codes
- Lot #: C04292401X1, BUD: 12/25/2025 (box).
- Distribution
- PA and CA.
- Quantity
- 20 boxes
- Recall started
- April 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0392-2025
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Class II Ongoing
Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.
Reason: cGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #: L0224T, K1824M, K0124N, J1624V, J0824O, I2424E, I1024O, A0925F, L2324L, Exp: 7/31/2026.
- Distribution
- Nationwide in the US
- Quantity
- 1190 Bottles
- Recall started
- April 18, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0391-2025
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Class II Ongoing
Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01
Reason: Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Lots, distribution and details
- Lots / codes
- Lot# : 3TF24001, Exp 3/31/2026
- Distribution
- USA nationwide.
- Quantity
- —
- Recall started
- April 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0390-2025
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Class II Ongoing
Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01
Reason: Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Lots, distribution and details
- Lots / codes
- Lot #: 3TF24002A, Exp 11/30/2026
- Distribution
- USA nationwide.
- Quantity
- 18,867 bags
- Recall started
- April 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0389-2025
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Class II Ongoing
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge P…
Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lots, distribution and details
- Product
- Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922
- Lots / codes
- Lot # 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026
- Distribution
- US Nationwide.
- Quantity
- 343,344 bottles
- Recall started
- April 14, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0388-2025
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Class II Ongoing
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-1…
Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lots, distribution and details
- Product
- Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
- Lots / codes
- Lot # 240987C, exp. date 04/2027 241014C, exp. date 04/2027
- Distribution
- US Nationwide.
- Quantity
- 16,473 bottles
- Recall started
- April 14, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0387-2025
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Class II Terminated
Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot# 201727/A/B/C/D/E & F, exp. date 05/31/2027, product # 3066 Lot# 208475/A/B/D/E/G/H & I, exp. date 09/30/2028, product # 3066
- Distribution
- US Nationwide.
- Quantity
- 161.6 grams
- Recall started
- March 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0386-2025
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Class III Terminated
HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.
Reason: Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Lots, distribution and details
- Product
- HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.
- Lots / codes
- 104024120001, Exp Date 06/01/2025; 104024120002, Exp Date 06/21/2025; 104025010001, Exp Date 07/13/2025; 104025010002, Exp Date 07/28/2025
- Distribution
- Nationwide in the USA
- Quantity
- 1,375 cassettes
- Recall started
- April 15, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0385-2025
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Class II Terminated
Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot, expiry: UDE-01, EXP: OCT 26
- Distribution
- DE
- Quantity
- 10,752 bottles
- Recall started
- April 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0384-2025
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Class II Terminated
Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-405-99
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot, expiry: EAT-01, EXP: MAR 27
- Distribution
- DE
- Quantity
- 6,048 bottles
- Recall started
- April 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0383-2025
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Class II Terminated
Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-403-02
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot, expiry: EAG-01, EXP: MAR 27
- Distribution
- DE
- Quantity
- 6,048 bottles
- Recall started
- April 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0382-2025
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Class II Terminated
Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-409-15
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot, expiry: KSE-01, EXP: OCT 26; KSE-02, EXP: FEB 27
- Distribution
- DE
- Quantity
- 20,048 bottles
- Recall started
- April 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0381-2025
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Class II Terminated
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot, expiry: DEE-01, EXP: OCT 26; DEE-02 EXP: FEB 27
- Distribution
- DE
- Quantity
- 27,648 bottles
- Recall started
- April 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0380-2025
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Class II Terminated
DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot EDD-01
- Distribution
- DE
- Quantity
- 9504 bottles
- Recall started
- April 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0379-2025
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Class II Ongoing
Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00
- Lots / codes
- Lot J0826722-121624 Exp. 12/31/2025 Lot J0820365-111324 Exp. 11/30/2025 Lot J0814691-101624 Exp. 10/31/2025
- Distribution
- PA
- Quantity
- 1,858 30-count blister cards
- Recall started
- March 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0378-2025
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Class II Terminated
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 681…
Reason: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Lots, distribution and details
- Product
- clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01
- Lots / codes
- Lot #: M300442, Exp Date: 6/30/2025
- Distribution
- USA nationwide
- Quantity
- 2724 bottles
- Recall started
- April 10, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0377-2025
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Class II Ongoing
Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, Croatia, Distributed by: Apipharma, LLC, 2331 West Alameda Drive, Tempe…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, Croatia, Distributed by: Apipharma, LLC, 2331 West Alameda Drive, Tempe, AZ 85282 UPC 3 858882 101363
- Lots / codes
- Lot #: 153211, Exp.: 2025-04; 210221, Exp.: 2026-05.
- Distribution
- AZ
- Quantity
- 5,095 cartons
- Recall started
- April 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0376-2025
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Class II Ongoing
Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318
- Lots / codes
- Lot #: A00001, Exp.: 2027-12; A00005, Exp.: 2027-01; B00001, Exp.:2028-02
- Distribution
- AZ
- Quantity
- 4,218 boxes
- Recall started
- April 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0375-2025
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Class II Ongoing
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes.
Lots, distribution and details
- Product
- Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
- Lots / codes
- Lot #:2530023, Exp.: 7/12/2025
- Distribution
- Nationwide in the U.S.A
- Quantity
- 16,655 syringes
- Recall started
- March 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0374-2025
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Class II Ongoing
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes.
Lots, distribution and details
- Product
- Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
- Lots / codes
- Lot #:2530019, Exp.: 7/10/2025; 2530053, Exp.: 7/19/2025.
- Distribution
- Nationwide in the U.S.A
- Quantity
- 49,830 syringes
- Recall started
- March 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0373-2025
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Class II Ongoing
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes.
Lots, distribution and details
- Lots / codes
- Lot #: 2431349A, Exp.: 6/16/2025
- Distribution
- Nationwide in the U.S.A
- Quantity
- 7,290 syringes
- Recall started
- March 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0372-2025
-
Class II Ongoing
dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes.
Lots, distribution and details
- Lots / codes
- Lot #: 2431276A, Exp.: 4/20/2025
- Distribution
- Nationwide in the U.S.A
- Quantity
- 23,610 syringes
- Recall started
- March 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0371-2025
-
Class II Ongoing
Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes.
Lots, distribution and details
- Lots / codes
- Lot #: 2431015B, Exp. 4/10/2025.
- Distribution
- Nationwide in the U.S.A
- Quantity
- 170 syringes
- Recall started
- March 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0370-2025
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.