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.
311 recalls
-
Class II Terminated
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 1223049625, Exp 1/24/24
- Distribution
- Nationwide in the USA
- Quantity
- 381 Bags
- Recall started
- November 9, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0394-2024
-
Class II Completed
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2…
Reason: Subpotent Drug: Out of specification for assay
Lots, distribution and details
- Product
- Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30.
- Lots / codes
- Lot #0013R; Exp. 01/2026
- Distribution
- Nationwide
- Quantity
- 3,600 cartons
- Recall started
- February 2, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0355-2024
-
Class II Ongoing
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71…
Reason: Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Lots, distribution and details
- Product
- Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1.
- Lots / codes
- Lot #s: 20230929VAS-2, Exp. 02/29/2024; 20231004VAS-2, Exp. 04/01/2024; Lot 20231010VAS-2,Exp. 04/07/2024; Lot 20231013VAS-2, Exp. 04/10/2024
- Distribution
- MN
- Quantity
- 1,299 syringes
- Recall started
- January 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0325-2024
-
Class I Ongoing
Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-5
Reason: Non-Sterility
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide within the United States
- Quantity
- 7,200 bottles
- Recall started
- November 13, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0306-2024
-
Class I Ongoing
LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-5
Reason: Non-Sterility
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide within the United States
- Quantity
- 6,024 bottles
- Recall started
- November 13, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0304-2024
-
Class I Ongoing
Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0089-1
Reason: Non-Sterility
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide within the United States
- Quantity
- 23,208 bottles
- Recall started
- November 13, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0299-2024
-
Class I Ongoing
CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-704-30), Distribut…
Reason: Non-Sterility
Lots, distribution and details
- Product
- CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-704-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.
- Lots / codes
- All lots
- Distribution
- Nationwide within the United States
- Quantity
- 150,720 bottles
- Recall started
- November 13, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0298-2024
-
Class I Ongoing
Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed…
Reason: Non-Sterility
Lots, distribution and details
- Product
- Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017
- Lots / codes
- All lots
- Distribution
- Nationwide within the United States
- Quantity
- 210,192 bottles
- Recall started
- November 13, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0291-2024
-
Class I Ongoing
CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-702-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-702-30), Distrib…
Reason: Non-Sterility
Lots, distribution and details
- Product
- CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-702-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-702-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.
- Lots / codes
- All lots
- Distribution
- Nationwide within the United States
- Quantity
- 386,256 bottles
- Recall started
- November 13, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0290-2024
-
Class I Ongoing
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Lots, distribution and details
- Lots / codes
- Lot #: 2331140, Exp. Date 02/08/2024; 2331188, Exp. Date 02/15/2024; 2331261, Exp. Date 03/05/2024; 2331287, Exp. Date 03/14/2024.
- Distribution
- Nationwide within the United States
- Quantity
- 7,548 IV bags
- Recall started
- December 28, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0282-2024
-
Class I Ongoing
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Lots, distribution and details
- Lots / codes
- Lot #: 2331184, Exp. Date 02/13/2024; 2331185, Exp. Date 02/10/2024; 2331189, Exp. Date 02/20/2024; 2331191, Exp. Date 02/24/2024; 2331258,Exp. Date 03/03/2024; 2331317, Exp. Date 03/15/2024.
- Distribution
- Nationwide within the United States
- Quantity
- 10,152 IV bags
- Recall started
- December 28, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0281-2024
-
Class I Ongoing
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Lots, distribution and details
- Lots / codes
- Lot #: 2330939, Exp. Date 01/30/2024; 2331032, Exp. Date 02/03/2024; 2331112, Exp. Date 03/19/2024; 2331190, Exp. Date 03/26/2024; 2331429, Exp. Date 04/28/2024.
- Distribution
- Nationwide within the United States
- Quantity
- 12,564 IV bags
- Recall started
- December 28, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0280-2024
-
Class I Ongoing
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Lots, distribution and details
- Lots / codes
- Lot #: 2330993, Exp. Date 02/15/2024; 2331010, Exp. Date 02/10/2024; 2331055, Exp. Date 01/18/2024; 2331113, Exp. Date 02/26/2024; 2331181, Exp. Date 03/04/2024; 2331187, Exp. Date 03/23/2024; 2331266, Exp. Date 03/31/2024; 2331343, Exp. Date 04/01/2024; 2331349, Exp. Date 04/23/2024; 2331433, Exp. Date 05/05/2024.
- Distribution
- Nationwide within the United States
- Quantity
- 29,016 IV bags
- Recall started
- December 28, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0279-2024
-
Class I Ongoing
FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Lots, distribution and details
- Lots / codes
- Lot #: 2330988, Exp. Date 01/31/2024; 2331058, Exp. Date 02/18/2024; 2331150, Exp. Date 03/10/2024; 2331231, Exp. Date 03/24/2024; 2331289, Exp. Date 03/30/2024.
- Distribution
- Nationwide within the United States
- Quantity
- 13,920 IV bags
- Recall started
- December 28, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0278-2024
-
Class I Ongoing
FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Lots, distribution and details
- Lots / codes
- Lot #: 2331062, Exp. Date: 02/08/2024; 2331224, Exp. Date 03/18/2024; 2331270, Exp. Date 03/28/2024.
- Distribution
- Nationwide within the United States
- Quantity
- 8,976 IV bags
- Recall started
- December 28, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0277-2024
-
Class II Ongoing
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1
Reason: Subpotent Drug
Lots, distribution and details
- Lots / codes
- Lot #: 20230921VAS-2, Exp. Date 03/19/2024
- Distribution
- MN only
- Quantity
- 281 syringes
- Recall started
- January 12, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0258-2024
-
Class I Ongoing
8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per Carton, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6637-24 (carton), 0409-66…
Reason: Presence of Particulate Matter; identified as glass
Lots, distribution and details
- Product
- 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per Carton, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6637-24 (carton), 0409-6637-14 (case).
- Lots / codes
- Lot HA7295, EXP 03/01/2025
- Distribution
- Nationwide in the USA and Puerto Rico.
- Quantity
- 21200 Cartons
- Recall started
- December 21, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0234-2024
-
Class I Ongoing
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton),…
Reason: Presence of Particulate Matter; identified as glass
Lots, distribution and details
- Product
- 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton), 0409-5534-14 (case).
- Lots / codes
- Lot GX1542, Exp. 01/01/2025
- Distribution
- Nationwide in the USA and Puerto Rico.
- Quantity
- 34000 Cartons
- Recall started
- December 21, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0233-2024
-
Class II Ongoing
Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Free Low Sodium, Grape flavor 10 fl. oz, Distributed by: Walgreen Co, 200 Wilmot Rd, Deerfield, IL 60015, NDC 0363-0427-98.
Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS – Presence of Acetobacter nitrogenifigens bacteria.
Lots, distribution and details
- Lots / codes
- Lot A80623; Exp. 11/30/2025
- Distribution
- Nationwide.
- Quantity
- 49,716 Bottles
- Recall started
- December 21, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0228-2024
-
Class II Terminated
Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Lots, distribution and details
- Product
- Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01
- Lots / codes
- Batch 2323041
- Distribution
- Nationwide USA
- Quantity
- 1 unit
- Recall started
- January 26, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0201-2024
-
Class II Terminated
Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1714-01
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Lots, distribution and details
- Product
- Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1714-01
- Lots / codes
- Batch 2169041
- Distribution
- Nationwide USA
- Quantity
- 1 unit
- Recall started
- January 26, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0200-2024
-
Class II Terminated
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Lots, distribution and details
- Product
- Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69
- Lots / codes
- Batch SAH06821A
- Distribution
- Nationwide USA
- Quantity
- 2 units
- Recall started
- January 26, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0179-2024
-
Class II Terminated
Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 1…
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Product
- Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. NDC 62756-589-88
- Lots / codes
- Lot DND0059A Expires 12/2023 Lot DND0060A Expires 12/2023 Lot DND0061A Expires 12/2023 Lot DND0062A Expires 01/2024 Lot DND0063A Expires 01/2024 Lot DND0064A Expires 01/2024 Lot DND0065A Expires 01/2024 Lot DND0180A Expires 01/2024 Lot DND0181A Expires 01/2024 Lot DND0182A Expires 01/2024 Lot DND0183A Expires 01/2024 Lot DND0184A Expires 01/2024 Lot DND0597A Expires 02/2024
- Distribution
- Nationwide
- Quantity
- 96,192 bottles
- Recall started
- December 4, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0150-2024
-
Class II Completed
ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26,
Reason: STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.
Lots, distribution and details
- Lots / codes
- Lot#: 23109472A, Exp. date 03/10/2024; 23109473A, Exp. date 03/11/2024; 23109474A, Exp. date 03/13/2024; 23109491A, Exp. date 03/16/2024; 23109492A, Exp. date 03/19/2024; 23109501A, Exp. date 03/25/2024; 23109520A, Exp. date 04/10/2024; 23109521A, Exp. date 04/13/2024; 23109522A, Exp. date 04/03/2024.
- Distribution
- Nationwide within the United States
- Quantity
- 2616 bags
- Recall started
- November 29, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0147-2024
-
Class II Completed
ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10
Reason: Lack of assurance of sterility.
Lots, distribution and details
- Lots / codes
- Lot # 11092313110#01, Exp 01/12/24
- Distribution
- Philadelphia, Pennsylvania.
- Quantity
- 825 syringes
- Recall started
- November 22, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0141-2024
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 1, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.