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 Terminated
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58
Reason: cGMP violations
Lots, distribution and details
- Lots / codes
- Lot # C274-000038958, exp. date 17-Oct-24 C274-000039206, exp. date 23-Oct-24
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Quantity
- 753 bags
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0022-2025
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Class II Terminated
Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59
Reason: cGMP violations
Lots, distribution and details
- Lots / codes
- Lot # C274-000038801, exp. date 9-Oct-24 C274-000039045, exp. date 24-Oct-24 C274-000039240, exp. date 31-Oct-24
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Quantity
- 4436 bags
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0021-2025
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Class II Terminated
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58
Reason: cGMP violations
Lots, distribution and details
- Lots / codes
- Lot # C274-000038404, exp. date 18-Nov-24
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Quantity
- 733 bags
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0020-2025
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Class II Terminated
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58
Reason: cGMP violations
Lots, distribution and details
- Lots / codes
- Lot # C274-000038582, exp. date 29-Nov-24
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Quantity
- 2151 bags
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0019-2025
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Class II Terminated
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
Reason: cGMP violations
Lots, distribution and details
- Lots / codes
- Lot # C274-000038004, exp. date 27-Nov-24
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Quantity
- 1082 bags
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0018-2025
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Class II Terminated
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58
Reason: cGMP violations
Lots, distribution and details
- Lots / codes
- Lot # C274-000038499, exp. date 21-Dec-24
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Quantity
- 1378 bags
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0017-2025
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Class II Terminated
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
Reason: cGMP violations
Lots, distribution and details
- Lots / codes
- Lot #C274-000037039, exp. date 9-Oct-24 C274-000037239, exp. date 21-Oct-24
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Quantity
- 2756 bags
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0016-2025
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Class II Terminated
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58
Reason: cGMP violations
Lots, distribution and details
- Lots / codes
- Lot # C274-000037046, exp. date 13-Oct-24
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Quantity
- 1631 bags
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0015-2025
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Class II Terminated
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
Reason: CGMP violations
Lots, distribution and details
- Lots / codes
- Lot# C274-000039006, exp. date 19-Jan-25
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Quantity
- 1313 bags
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0014-2025
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Class II Ongoing
First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-…
Reason: Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Lots, distribution and details
- Product
- First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-1271-80
- Lots / codes
- Lot, expiry: Lot 220901, Exp. 09/30/2024; Lot 230701, Exp. 07/31/2026; Lot 230301, Exp. 03/31/2026; Lot 230401, Exp. 04/30/2026; Lot 230501, Exp. 05/31/2026; Lot 230801, Exp. 08/31/2026; Lot 240301, Exp. 03/31/2027; Lot 240501, Exp. 04/30/2027.
- Distribution
- Distributed to one wholesaler in OH for Nationwide distribution.
- Quantity
- 295,164 tubes
- Recall started
- September 11, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0013-2025
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Class I Terminated
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
Reason: Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Lots, distribution and details
- Lots / codes
- Lot # 2310083, Exp. 09/30/2025
- Distribution
- Nationwide in the U.S.A.
- Quantity
- 1,980 bottles
- Recall started
- September 17, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0012-2025
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Class II Ongoing
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.
Reason: Crystallization
Lots, distribution and details
- Lots / codes
- Lot #: T400512, Exp 02/28/2026
- Distribution
- NY
- Quantity
- 2544 pumps
- Recall started
- September 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0011-2025
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Class II Terminated
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahm…
Reason: Failed Impurities/Degradation Specifications.
Lots, distribution and details
- Product
- Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India. Mfg. Lic. No.: G/28/1336, NDC 16729-288-38
- Lots / codes
- Lot #: P2202009, Exp. Date: 03/2025
- Distribution
- Nationwide within the United States and PR
- Quantity
- 11,214 vials
- Recall started
- October 1, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0010-2025
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Class II Completed
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lots, distribution and details
- Lots / codes
- Lot #: 220128, Exp. Date 12/2024
- Distribution
- Product was distributed nationwide within the United States
- Quantity
- 7,107 bottles
- Recall started
- October 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0009-2025
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Class I Ongoing
Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.
Reason: Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Lots, distribution and details
- Lots / codes
- All lots within expiry
- Distribution
- Distributed via Amazon and 123Herbals.com website
- Quantity
- unknown
- Recall started
- September 18, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0008-2025
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Class II Ongoing
Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010…
Reason: CGMP deviations
Lots, distribution and details
- Product
- Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61
- Lots / codes
- Lot#: LPS240919B-16, 24-Sep-2024 Lot#: LPS240920B-16, 25-Sep-2024 Lot#: LPS240920C-16, 25-Sep-2024
- Distribution
- FL, MA, NJ, NY, PA, and VA
- Quantity
- 99 doses
- Recall started
- September 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0007-2025
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Class II Ongoing
Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43328, hikma, Glenmark…
Reason: Defective Delivery System: The dip tube is clogged causing the spray not to work.
Lots, distribution and details
- Product
- Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43328, hikma, Glenmark Specialty SA. NDC 59467-700-27.
- Lots / codes
- Lots 14230425, Exp Date, Nov-25; 14240024, Exp Date Dec-25; 14240029, Exp Date Dec-25; 14240076, Exp Date Jan-26; 14240082 Exp Date, Jan-26, 14240090, Exp Date Jan-26; and 14240100, Exp Date Jan-26
- Distribution
- Nationwide in the USA
- Quantity
- 45,504 bottles
- Recall started
- September 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0006-2025
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Class I Terminated
Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2
Reason: Presence of Particulate Matter: Presence of glass particle.
Lots, distribution and details
- Lots / codes
- Lot: 47035CFA, Exp. 11/2025
- Distribution
- Nationwide in the U.S.A.
- Quantity
- 105,000 vials
- Recall started
- September 19, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0005-2025
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Class I Ongoing
Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199
Reason: Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1)
- Quantity
- 615
- Recall started
- July 12, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0004-2025
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Class I Ongoing
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
Reason: Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1)
- Quantity
- 729
- Recall started
- July 12, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0003-2025
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Class III Ongoing
Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceutic…
Reason: Defective Container: Firm received complaints of broken tube at the seal.
Lots, distribution and details
- Product
- Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
- Lots / codes
- Lot #s: a) 19242028, Exp. 04/30/2026; b) 19242028, Exp. 04/30/2026; c) 19242028, Exp. 04/30/2026
- Distribution
- Nationwide in the US.
- Quantity
- 11,568 tubes
- Recall started
- September 30, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0002-2025
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Class II Terminated
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, I…
Reason: Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Lots, distribution and details
- Product
- Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.
- Lots / codes
- Lot #: U24T0408A, Exp: 03/31/2026
- Distribution
- Nationwide within the U.S
- Quantity
- 2328 bottles
- Recall started
- September 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0001-2025
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Class II Ongoing
Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12.
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Lots / codes
- Lots 22123437, 22123438, 22123535, Exp Date 9/30/24; 22123536, 22123537, 22123538, 22123646, 22123647, Exp Date 10/31/24; 23120529, 23120530, Exp Date 1/31/25; 23120703, 23120705, Exp Date 2/28/25; 23121429, 23121726, 23122049, 23122097, Exp Date, 4/30/25; 23121984, 23121985, 23121986, Exp Date 5/31/25; 23122325, 23122329, 23122330, 23122331, Exp Date 6/30/26; 23122776, 23122852, 23122853, 23123154, 23123155, Exp Date 8/31/26; 23123458, Exp Date 9/30/26.
- Distribution
- Nationwide in the USA and PR
- Quantity
- 117,493 bottles
- Recall started
- September 3, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0668-2024
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Class II Ongoing
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
Reason: CGMP deviations
Lots, distribution and details
- Lots / codes
- Lot #: 042224-L1, Exp. Date 04/22/2025
- Distribution
- Product was sent to one distributor in North Carolina.
- Quantity
- 120 bottles
- Recall started
- September 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0667-2024
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Class II Ongoing
Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370 Lawrenceville Hwy NW, P.O. Box 2204, Lilburn, GA 30047-1100, USA. Ph.: 872 216 1566, http://www.dala…
Reason: Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Lots, distribution and details
- Product
- Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370 Lawrenceville Hwy NW, P.O. Box 2204, Lilburn, GA 30047-1100, USA. Ph.: 872 216 1566, http://www.dalayurevda.com, Made in India, UPC: 042535355019
- Lots / codes
- Batch # IN-032, Exp 11/30/2027
- Distribution
- Retail: South Carolina, North Carolina, Ohio; Consumer level: Nationwide within USA
- Quantity
- —
- Recall started
- June 26, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0666-2024
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 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.