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.
1,094 recalls
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Class III Ongoing
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot H2200493; Exp 6/30/2025
- Distribution
- US Nationwide.
- Quantity
- 1,176 bottles
- Recall started
- May 1, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0504-2024
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Class II Ongoing
Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Meijer Distribution Inc., Grand Rapids,MI 49544, NDC 79481-0034-9
Reason: Microbial Contamination of Non-Sterile Products – Presence of Acetobacter nitrogenifigens bacteria
Lots, distribution and details
- Lots / codes
- Lot #: A81834, Exp 1/31/2026
- Distribution
- USA Nationwide
- Quantity
- 24840
- Recall started
- May 1, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0501-2024
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Class II Ongoing
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.
Reason: Microbial Contamination of Non-Sterile Products – Presence of Acetobacter nitrogenifigens bacteria
Lots, distribution and details
- Lots / codes
- Lot #: A81506, Exp 12/31/2025
- Distribution
- USA Nationwide
- Quantity
- 120830
- Recall started
- May 1, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0500-2024
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Class I Terminated
Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV.
Reason: Marketed Without An Approved NDA/ANDA
Lots, distribution and details
- Lots / codes
- Lot 2108; EXP 10/31/2024
- Distribution
- Distribution worldwide via amazon.com
- Quantity
- 5 boxes
- Recall started
- April 22, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0494-2024
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Class II Ongoing
Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-3893…
Reason: Out of specification for assay
Lots, distribution and details
- Product
- Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01
- Lots / codes
- Lot #: BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026
- Distribution
- Nationwide within the United States
- Quantity
- 11,016 vials
- Recall started
- April 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0493-2024
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Class II Ongoing
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, E…
Reason: Discoloration: Dotted and yellow spots on tablets
Lots, distribution and details
- Product
- Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
- Lots / codes
- Lot #s: a) CZB124001B, CZB124002B, CZB124003B, Exp. 12/31/2025; b) CZB124001A, CZB124003A, Exp. 12/31/2025.
- Distribution
- Nationwide in the USA
- Quantity
- 6909 bottles
- Recall started
- April 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0492-2024
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Class II Ongoing
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, E…
Reason: Discoloration: Dotted and yellow spots on tablets
Lots, distribution and details
- Product
- Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
- Lots / codes
- Lot #s: a) CZA124001B, CZA124002B, CZA124003B, Exp. 12/31/2025; b) CZA124001A, CZA124003A, Exp. 12/31/2025.
- Distribution
- Nationwide in the USA
- Quantity
- 6696 bottles
- Recall started
- April 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0491-2024
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Class II Terminated
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Ph…
Reason: Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Lots, distribution and details
- Product
- Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ
- Lots / codes
- Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.
- Distribution
- New Jersey Only
- Quantity
- 382,104 units
- Recall started
- April 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0488-2024
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Class II Ongoing
traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited…
Reason: Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Lots, distribution and details
- Product
- traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00
- Lots / codes
- Lot #: 230774Hl, Exp 4/30/2026
- Distribution
- Nationwide in the USA
- Quantity
- 2,592 1000-count Bottles
- Recall started
- April 26, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0487-2024
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Class I Ongoing
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
Reason: Sub-potent Drug; powder discoloration associated with decreased potency
Lots, distribution and details
- Lots / codes
- Lot # T2200352, Exp. 12/31/2024
- Distribution
- Nationwide in the USA
- Quantity
- 2402 cartons
- Recall started
- April 8, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0486-2024
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Class I Ongoing
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.
Reason: Sub-potent Drug; powder discoloration associated with decreased potency
Lots, distribution and details
- Lots / codes
- Lot #: T2202812, Exp. 07/31/2025; T2204053, Exp. 10/31/2025; T2300975, T2300976, Exp. 02/28/2026; T2304356, Exp. 08/31/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 17,332 cartons
- Recall started
- April 8, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0485-2024
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Class III Completed
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables…
Reason: Labeling: Wrong Barcode
Lots, distribution and details
- Product
- Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05
- Lots / codes
- Lot #: CH0324001, Exp. Date 3/4/2025
- Distribution
- Nationwide within the United States
- Quantity
- 1,895 bags
- Recall started
- April 30, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0480-2024
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Class II Completed
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Lots / codes
- Lot #: BJ01922A, exp. date 03/2024
- Distribution
- US Nationwide.
- Quantity
- 2784 bottles
- Recall started
- March 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0477-2024
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Class I Ongoing
ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide in the USA
- Quantity
- 4,351 pieces
- Recall started
- March 19, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0457-2024
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Class I Ongoing
The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Mesa, A, UPC 6 61631 26363 1.
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide in the USA
- Quantity
- 10 boxes
- Recall started
- March 19, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0456-2024
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Class I Terminated
Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal P…
Reason: Superpotent Drug: Due to overfilling of drug powder
Lots, distribution and details
- Product
- Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
- Lots / codes
- Lot # (a) 22613003A, Exp. date 09/30/2025; (b) 22613004A, 22613005A, Exp. date 09/30/2025; (c) 22613005B, Exp. date 09/30/2025
- Distribution
- Nationwide in the USA.
- Quantity
- 821 bottles
- Recall started
- March 21, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0442-2024
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Class II Terminated
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdi…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
- Lots / codes
- Lot#: 411988, Exp date: 05/31/2025
- Distribution
- Nationwide in the US
- Quantity
- 30 bottles
- Recall started
- March 27, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0438-2024
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Class I Ongoing
Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01
Reason: Presence of Particulate Matter.
Lots, distribution and details
- Product
- Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01
- Lots / codes
- Lot#: 57014; Exp, 04/30/2024
- Distribution
- Nationwide in the USA
- Quantity
- 466 vials
- Recall started
- March 4, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0429-2024
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Class II Terminated
VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01
Reason: cGMP Diviations
Lots, distribution and details
- Lots / codes
- Lot # 1G008A/1G00804722, Exp 07/31/25
- Distribution
- USA nationwide.
- Quantity
- 17,280 paper cartons
- Recall started
- March 21, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0427-2024
-
Class II Terminated
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 651…
Reason: Failed dissolution specifications
Lots, distribution and details
- Product
- Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10
- Lots / codes
- Lot # AR210704, exp. date 04/2024 AR210706, exp. date 04/2024 AR210707, exp. date 04/2024 AR210708, exp. date 04/2024 AR210709, exp. date 04/2024
- Distribution
- Product was distributed nationwide.
- Quantity
- 21,452/100 count bottles
- Recall started
- December 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0426-2024
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Class I Terminated
Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.
Reason: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Lots, distribution and details
- Lots / codes
- All lots within expiry
- Distribution
- Nationwide in the U.S.
- Quantity
- 3,573 bottles
- Recall started
- February 5, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0393-2024
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Class II Ongoing
Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11
Reason: Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Lots, distribution and details
- Lots / codes
- Lot #: 3NC22019, Exp. Date 2/24
- Distribution
- Nationwide within the United States
- Quantity
- 43,920 vials
- Recall started
- February 20, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0391-2024
-
Class II Ongoing
Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10
Reason: Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Lots, distribution and details
- Product
- Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10
- Lots / codes
- Lot #: 3NC23002, Exp. Date 7/24; 3NC22013, 3NC22014, 3NC22015, 3NC22016, 3NC22017, 3NC22018, Exp. Date 2/24; 3NC22020, Exp. Date 3/24
- Distribution
- Nationwide within the United States
- Quantity
- 335,940 vials
- Recall started
- February 20, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0390-2024
-
Class III Ongoing
Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
Reason: Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Lots, distribution and details
- Lots / codes
- Lot #: 119466, 119467 Exp 04/2025; 120351 Exp 08/2025; 121712 Exp 11/2025
- Distribution
- Nationwide in the U.S. and Puerto Rico
- Quantity
- 45,875 bottles
- Recall started
- February 20, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0364-2024
-
Class II Terminated
7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033
Reason: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Lots, distribution and details
- Lots / codes
- Lot #: 251176, Exp. 06/23/2024.
- Distribution
- Nationwide in the US and Puerto Rico
- Quantity
- 3 cases
- Recall started
- February 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0358-2024
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.