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
-
Class I Ongoing
Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10
Reason: Presence of Particulate Matter
Lots, distribution and details
- Lots / codes
- Lot #: 3MC23011, Exp 11/30/2026
- Distribution
- Nationwide in the USA
- Quantity
- 1,552 10ml x 25/carton
- Recall started
- February 15, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0440-2024
-
Class II Ongoing
Isotretinoin Capsules, USP 40mg, 30-count 3×10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
Reason: Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Lots, distribution and details
- Product
- Isotretinoin Capsules, USP 40mg, 30-count 3×10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
- Lots / codes
- Lot #: 100044259, Exp 06/30/2025.
- Distribution
- Nationwide in the USA
- Quantity
- 5,304 3×10-cartons
- Recall started
- March 28, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0439-2024
-
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
-
Class II Terminated
Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659-06
Reason: Subpotent Drug
Lots, distribution and details
- Lots / codes
- Lot #: A201064, Exp. Date March 2024
- Distribution
- Nationwide within the United States
- Quantity
- 26,352 bottles
- 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-0437-2024
-
Class II Ongoing
FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fen…
Reason: Lack of Assurance of Sterility: Firm did not perform process validation.
Lots, distribution and details
- Product
- FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1
- Lots / codes
- Lot: 20231031-0C91D9, Exo 29-Feb-2024.
- Distribution
- MO
- Quantity
- 140 vials
- Recall started
- February 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0436-2024
-
Class II Ongoing
Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug – Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles…
Reason: Lack of Assurance of Sterility: Firm did not perform process validation.
Lots, distribution and details
- Product
- Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug – Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1
- Lots / codes
- Lot #s: 20240109-837CB8, Exp. 07-Jul-2024; 20231219-08D09D, Exp. 16-Jun-2024; 20231121-20F8BB, Exp. 19-May-2024; 20231115-2FF64D, Exp. 13-May-2024; 20231101-09C52B, Exp. 29-Apr-2024; 20231010-3D0B35, Exp. 07-Apr-2024; 20230912-847E0C, Exp. 10-Mar-2024.
- Distribution
- MO
- Quantity
- 11,798 syringes
- Recall started
- February 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0435-2024
-
Class III Terminated
Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous…
Reason: Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Lots, distribution and details
- Product
- Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01.
- Lots / codes
- Lot #: CIC2-23001 A, Exp. 11/30/2026
- Distribution
- Nationwide in the US
- Quantity
- 1332 vials
- Recall started
- April 2, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0434-2024
-
Class III Terminated
Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.
Reason: Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Lots, distribution and details
- Lots / codes
- Lot #: CIC1-23001 A, Exp. 08/30/2026
- Distribution
- Nationwide in the US
- Quantity
- 1283 vials
- Recall started
- April 2, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0433-2024
-
Class II Ongoing
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
Reason: Lack of Assurance of Sterility: leaking bags
Lots, distribution and details
- Lots / codes
- Lot#: 20231020FEN-1, Exp: 04/17/2024
- Distribution
- Nationwide within the U.S
- Quantity
- 187 cassettes
- Recall started
- March 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0432-2024
-
Class II Terminated
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
Reason: Lack of assurance of sterility: bags have the potential to leak..
Lots, distribution and details
- Lots / codes
- Lot #: J3N023, Exp: 31 March 2026
- Distribution
- Nationwide in the USA
- Quantity
- 7,800 bags
- Recall started
- March 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0431-2024
-
Class II Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562…
Reason: Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Lots, distribution and details
- Product
- Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01
- Lots / codes
- Lot #: 17230304, Exp. 12/31/2024.
- Distribution
- Nationwide in the US
- Quantity
- 6,528 bottles
- Recall started
- March 26, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0430-2024
-
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
-
Class II Terminated
Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP – triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 009…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP – triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 0093-2140-62
- Lots / codes
- Lot # 100039678, Exp 04/31/2024; 100038111, 100042277, Exp 07/31/2024
- Distribution
- USA nationwide.
- Quantity
- 92,676 cartons
- Recall started
- March 7, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0428-2024
-
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
-
Class II Terminated
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 1223049049 Exp 12/28/23
- Distribution
- Nationwide in the USA
- Quantity
- 368 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-0425-2024
-
Class II Terminated
SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 70004090809
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #:1223049085 Exp 11/29/23; 1223049364 Exp 12/12/23
- Distribution
- Nationwide in the USA
- Quantity
- 5,079 syringe
- 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-0424-2024
-
Class II Terminated
SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-12, Bar Code 70004090812
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 1223049047 Exp 11/29/23; 1223049221 Exp 12/06/23; 1223049343 Exp 12/12/23; 1223049423 Exp 12/14/23; 1223049451 Exp 12/14/23; 1223049452 Exp 12/14/23; 1223049482 Exp 12/14/23
- Distribution
- Nationwide in the USA
- Quantity
- 8,755 syringe
- 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-0423-2024
-
Class II Terminated
Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 1223048444 Exp 11/20/23; 1223049011 Exp 12/12/23; 1223049673 Exp 01/09/24; 1223049771 Exp 01/12/24
- Distribution
- Nationwide in the USA
- Quantity
- 9,624 syringes
- 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-0422-2024
-
Class II Terminated
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12-K, Bar Code 7000…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12-K, Bar Code 700040081612. (same finished product as F078140, but with RFID for KitCheck compatibility)
- Lots / codes
- Lot #: 1223048610 Exp 04/10/24; 1223048611 Exp 04/10/24; 1223048726 Exp 04/13/24; 1223050163 Exp 06/12/24
- Distribution
- Nationwide in the USA
- Quantity
- 2,427 syringes
- 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-0421-2024
-
Class II Terminated
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040081612.
- Lots / codes
- Lot #: 1223045974 Exp 12/18/23; 1223046535 Exp 01/11/24; 1223049152 Exp 05/02/24 Expanded Lot #: 1223048067, Exp 04/06/2024; 1223048792, Exp 04/17/2024.
- Distribution
- Nationwide in the USA
- Quantity
- 3,671 syringes, expanded 1,911 syringes
- 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-0420-2024
-
Class II Terminated
PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 1223050005 Exp 01/13/24
- Distribution
- Nationwide in the USA
- Quantity
- 400 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-0419-2024
-
Class II Terminated
PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004081112.
- Lots / codes
- Lot #: 1223045040 Exp 11/13/23, 1223046397 Exp 01/06/24, 1223046505 Exp 01/10/24, 1223047254 Exp 02/08/24, 1223047436 Exp 02/15/24, 1223047938 Exp 03/13/24, 1223049150 Exp 05/02/24, 1223049300 Exp 05/09/24, Expanded Lot #: 1223048569, Exp 04/06/2024; 1223049600, Exp 05/19/2024
- Distribution
- Nationwide in the USA
- Quantity
- 10,017 syringes, expanded 2579 syringes
- 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-0418-2024
-
Class II Terminated
PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 1223045282 Exp 11/24/23; 1223045370 Exp 11/26/23; 1223045624 Exp 12/07/23; 1223045723 Exp 12/10/23; 1223045732 Exp 12/10/23; 1223046128 Exp 12/24/23; 1223046133 Exp 12/24/23; 1223047112 Exp 02/02/24; 1223047232 Exp 2/07/24; 1223047398 Exp 02/15/24; 1223047456 Exp 02/16/24; 1223047569 Exp 02/18/24; 1223047694 Exp 02/24/24; 1223047780 Exp 03/07/24; 1223047859 Exp 03/08/24; 1223048119 Exp 03/20/24; 1223048183 Exp 03/22/24; 1223048837 Exp 04/18/24; 1223048838 Exp 04/18/24; 1223048982 Exp 04/24/24; 1223049144 Exp 05/02/24; 1223049145 Exp 05/02/24; 1223049147 Exp 05/02/24; 1223049821 Exp 05/30/24 Expanded Lot #: 1223048037, Exp 03/16/2024; 1223048047, Exp 03/17/2024; 1223049146, 1223049149, Exp 05/02/2024; 1223049373, Exp 05/10/2024; 1223048909, Exp 04/20/2024; 1223048696, Exp 04/12/2024; 1223050181, Exp 06/12/2024
- Distribution
- Nationwide in the USA
- Quantity
- 5,948 syringes, expanded 2,102 syringes
- 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-0417-2024
-
Class II Terminated
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 7000…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID for KitCheck
- Lots / codes
- Lot #: 1223048431 exp 04/05/24; 1223049023 exp 04/25/24
- Distribution
- Nationwide in the USA
- Quantity
- 1,118 syringes in kits
- 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-0416-2024
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 4, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.