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.
3,228 recalls
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Class I Ongoing
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made i…
Reason: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Lots, distribution and details
- Product
- Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.
- Lots / codes
- Lot # 25ZF3670, Exp Date: May 31, 2027.
- Distribution
- Distributed Nationwide in the US and Mexico.
- Quantity
- 3,486 500mL-vials
- Recall started
- July 31, 2026 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0773-2026
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Class I Ongoing
Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.
Reason: Microbial Contamination of Sterile Products – out of specifications results were obtained for bacterial endotoxin.
Lots, distribution and details
- Lots / codes
- Lot # 1984345, 1980571, 1981940, Use Before Date: 08/27/2026.
- Distribution
- USA Nationwide
- Quantity
- 91
- Recall started
- July 1, 2026 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0772-2026
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Class I Ongoing
Kian Pee Wan Capsules, 30-count bottles
Reason: Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
Lots, distribution and details
- Lots / codes
- All lots within expiry.
- Distribution
- Product was sold to individual consumers via ebay third party seller.
- Quantity
- 71 bottles
- Recall started
- March 21, 2026 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0769-2026
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Class II Ongoing
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51
Reason: Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Lots, distribution and details
- Lots / codes
- Lot #: 2411550, Exp. 2026/NOV.
- Distribution
- Nationwide within the U.S
- Quantity
- —
- Recall started
- July 30, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0768-2026
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Class II Ongoing
CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3
Reason: Lack of assurance of sterility. The recall is due to potential contamination
Lots, distribution and details
- Product
- CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3
- Lots / codes
- Lot 2552A, Exp 09/30/2027
- Distribution
- Nationwide in the USA.
- Quantity
- 39,060 15mL-bottles
- Recall started
- July 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0766-2026
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Class II Ongoing
SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 3827…
Reason: CGMP Deviations:Noted during FDA inspection
Lots, distribution and details
- Product
- SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.
- Lots / codes
- Lot: SDC2505001, Date of Expiry: April 30, 2030.
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 25 KG, 25 X 1.00 KG bags
- Recall started
- August 3, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0763-2026
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Class II Ongoing
TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India,…
Reason: CGMP Deviations:Noted during FDA inspection
Lots, distribution and details
- Product
- TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08
- Lots / codes
- Batch TLF2506001, Date of Expiry: May 31, 2028.
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 1KG – 20 X 1KG(1000gm) bags
- Recall started
- August 3, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0762-2026
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Class II Ongoing
TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, In…
Reason: CGMP Deviations:Noted during FDA inspection
Lots, distribution and details
- Product
- TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04.
- Lots / codes
- Batch TLF2506001, Date of Expiry: May 31, 2028.
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 20 KG, 40 X 0.500KG(500gm) bags
- Recall started
- August 3, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0761-2026
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Class II Ongoing
TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, Indi…
Reason: CGMP Deviations:Noted during FDA inspection
Lots, distribution and details
- Product
- TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02.
- Lots / codes
- Lot: TLF2506001, Date of Expiry: May 31, 2028.
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 1KG – 100-0.1KG(100gm) bags
- Recall started
- August 3, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0760-2026
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Class II Ongoing
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 3827…
Reason: CGMP Deviations:Noted during FDA inspection
Lots, distribution and details
- Product
- SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05
- Lots / codes
- Batch SDC2505001, Date of Expiry: April 30, 2030.
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 25KG, 250-1gm bags
- Recall started
- August 3, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0759-2026
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Class II Ongoing
SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-724-04.
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Lots, distribution and details
- Lots / codes
- Lot: AC-017275, Exp. 12/13/2026; AC-017282, AC-017285, Exp. 12/27/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 4,250 vials.
- Recall started
- July 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0757-2026
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Class II Ongoing
SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-722-02
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Lots, distribution and details
- Lots / codes
- Lot: AC-017274, Exp. 12/12/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 500 vials.
- Recall started
- July 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0756-2026
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Class II Ongoing
SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Lots, distribution and details
- Lots / codes
- Lot: AC-017273, Exp. 12/12/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 250 vials.
- Recall started
- July 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0755-2026
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Class II Ongoing
SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202.NDC 71170-712-03
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Lots, distribution and details
- Lots / codes
- Lot: AC-017272, Exp. 12/12/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 250 vials.
- Recall started
- July 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0754-2026
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Class II Ongoing
SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Lots, distribution and details
- Lots / codes
- Lot: AC-017271, Exp. 12/12/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 250 vials.
- Recall started
- July 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0753-2026
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Class II Ongoing
SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Lots, distribution and details
- Lots / codes
- Lot: AC-017131, Exp. 8/30/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 4,748 vials.
- Recall started
- July 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0752-2026
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Class II Ongoing
SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-822-02
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Lots, distribution and details
- Lots / codes
- Lot: AC-017125, Exp. 8/30/2026; AC-017138, AC-017147, AC-017214, AC-017226, AC-017228, Exp. 12/31/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 24,608 vials.
- Recall started
- July 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0751-2026
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Class II Ongoing
SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Lots, distribution and details
- Lots / codes
- Lot: AC-017124, Exp. 8/30/2026; AC-017136, Exp. 12/31/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 9,762 vials.
- Recall started
- July 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0750-2026
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Class II Ongoing
SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Lots, distribution and details
- Lots / codes
- Lot: C-017115, Exp. 11/25/2026; AC-017163, Exp. 12/31/2026; AC-017169, AC-017170, AC-017171, Exp. 12/31/2026; AC-017230, AC-017231, Exp. 5/5/2027.
- Distribution
- Nationwide within the U.S
- Quantity
- 37,546 vials.
- Recall started
- July 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0749-2026
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Class II Ongoing
SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Lots, distribution and details
- Lots / codes
- Lot: AC-017114, Exp. 11/24/2026; AC-017164, AC-017204, AC-017205, Exp. 12/31/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 23,029 vials.
- Recall started
- July 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0748-2026
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Class II Ongoing
SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Lots, distribution and details
- Lots / codes
- Lot: AC-017108, Exp. 11/17/2026; AC-017110, Exp. 11/20/2026; AC-017112, Exp. 11/21/2026; AC-017142, AC-017144, Exp. 12/10/2026; AC-017166, AC-017167, AC-017177, AC-017213, AC-017224, AC-017225, Exp. 12/31/2026
- Distribution
- Nationwide within the U.S
- Quantity
- 56,918 vials.
- Recall started
- July 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0747-2026
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Class II Ongoing
Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Lots / codes
- Lot AV5913C, Expiry: 6/2027
- Distribution
- US Nationwide
- Quantity
- —
- Recall started
- August 4, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0746-2026
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Class II Ongoing
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-…
Reason: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Lots, distribution and details
- Product
- Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.
- Lots / codes
- Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
- Distribution
- Nationwide in the USA
- Quantity
- —
- Recall started
- August 5, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0745-2026
-
Class I Ongoing
Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1
Reason: Presence of Particulate Matter; identified as stainless steel
Lots, distribution and details
- Product
- Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1
- Lots / codes
- Lot # V24010V1, Exp 3/31/2027
- Distribution
- USA Nationwide
- Quantity
- 1,464 vials
- Recall started
- July 17, 2026 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0744-2026
-
Class I Ongoing
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1
Reason: Presence of Particulate Matter; identified as stainless steel
Lots, distribution and details
- Product
- Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1
- Lots / codes
- Lot # C23019V1, Exp 10/31/2026; C24015V1, Exp 4/30/2027
- Distribution
- USA Nationwide
- Quantity
- 4,077 vials
- Recall started
- July 17, 2026 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0743-2026
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 November 1, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.