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 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, Bar Code 700040…
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, Bar Code 70004081011
- Lots / codes
- Lot #: 1223045053 Exp 11/15/23; 1223046179 Exp 12/28/23; 1223047477 Exp 02/16/24; 1223047602 Exp 02/22/24; 1223047971 Exp 03/14/24; 1223048269 Exp 03/27/24 Expanded lot#: 1223048181, exp. date 03/22/2024
- Distribution
- Nationwide in the USA
- Quantity
- 7,198 syringes; expanded 1,289 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-0415-2024
-
Class II Terminated
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 700…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012
- Lots / codes
- Lot #: 1223045536 Exp 12/06/23; 1223045710 Exp 12/10/23; 1223046574 Exp 01/12/24; 1223047579 Exp 02/21/24; 1223047764 Exp 03/06/24; 1223048363 Exp 03/30/24; 1223048364 Exp 03/30/24; 1223048566 Exp 04/06/24; 1223048573 Exp 04/07/24; 1223048574 Exp 04/07/24; 1223048643 Exp 04/11/24; 1223048697 Exp 04/12/24; 1223048742 Exp 04/13/24 Expanded lots#: 1223048065, Exp 04/06/2024; 1223048395, 1223048397, Exp 03/27/2024; 1223049980, Exp 06/05/2024
- Distribution
- Nationwide in the USA
- Quantity
- 33,072 syringes; expanded 9,041 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-0414-2024
-
Class II Terminated
neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 1223048138 exp 1/31/24
- Distribution
- Nationwide in the USA
- Quantity
- 1,122 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-0413-2024
-
Class II Terminated
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot#: 1223044958 Exp 11/10/23; 1223045436 Exp 11/30/23; 1223046132 Exp 12/28/23; 1223046385 Exp 01/06/24; 1223048807 Exp 04/17/24; 1223049030 Exp 04/26/24 Expanded Recall lots: 1223049328, Exp 05/10/2024;1223048948, Exp 04/21/2024; 1223048631, Exp 04/10/2024; 1223050389, Exp 06/21/2024.
- Distribution
- Nationwide in the USA
- Quantity
- 1,508 bags; expanded 1,015 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-0412-2024
-
Class II Terminated
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 1223047334 Exp 12/23/23; 1223048170 Exp 02/01/24
- Distribution
- Nationwide in the USA
- Quantity
- 2,458, 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-0411-2024
-
Class II Terminated
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321
- Lots / codes
- Lot#: 1223048258 Exp 11/10/23; 1223048890 Exp 12/07/23; 1223049134 Exp 12/19/23
- Distribution
- Nationwide in the USA
- Quantity
- 909 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-0410-2024
-
Class II Terminated
HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-16, Bar Cod…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-16, Bar Code 70004030316
- Lots / codes
- Lot #: 1223048357 Exp 11/15/23; 1223048461 EXP 11/20/23; 1223048486 EXP 11/21/23; 1223048694 EXP 12/01/23; 1223048865 EXP 12/06/23; 1223048967 EXP 12/11/23; 1223049098 EXP 12/15/23; 1223049133 EXP 12/19/23; 1223049175 EXP 12/20/23; 1223049268 EXP 12/25/23; 1223049457 EXP 01/01/24; 1223049561 EXP 01/04/24; 1223049604 EXP 01/05/24; 1223049648 EXP 01/09/24; 1223049870 EXP 01/17/24; 1223049942 EXP 01/19/24; 1223049973 EXP 01/23/24; 1223050060 EXP 01/25/24;
- Distribution
- Nationwide in the USA
- Quantity
- 5392 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-0409-2024
-
Class II Terminated
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 700403031…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 7004030317
- Lots / codes
- Lot #: 1223048491 Exp 11/21/23
- Distribution
- Nationwide in the USA
- Quantity
- 399 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-0408-2024
-
Class II Terminated
HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022
- Lots / codes
- Lot#: 1223048801 Exp 12/04/23; 1223049225 Exp 12/21/23; 1223049264 Exp 12/25/23; 1223049291 Exp 12/26/23; 1223049726 exp 01/11/24
- Distribution
- Nationwide in the USA
- Quantity
- 1,023 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-0407-2024
-
Class II Terminated
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 70004030018
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 70004030018
- Lots / codes
- Lot #: 1223048451 Exp 11/20/23; 1223048923 Exp 12/07/23; 1223049097 Exp 12/15/23; 1223049129 Exp 12/19/23;
- Distribution
- Nationwide in the USA
- Quantity
- 1,425 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-0406-2024
-
Class II Terminated
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-16, Bar C…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-16, Bar Code 70004030016
- Lots / codes
- Lot #: 1223048530, Exp 11/22/23; 1223048692 Exp 11/29/23; 1223048739 EXP 11/30/23; 1223048826 Exp 12/05/23; 1223048963 Exp 12/08/23; 1223048964 EXP 12/11/23; 1223049111 Exp 12/15/23; 1223049128 Exp12/19/23; 1223049210 EXP 12/21/23; 1223049234 Exp 12/22/23; 1223049257 Exp 12/22/23; 1223049322 Exp 12/27/23; 1223049416 Exp 12/28/23; 1223049528 Exp 01/03/24; 1223049559 Exp 01/04/24; 1223049614 Exp 01/05/24; 1223049632 Exp 01/08/24; 1223049725 Exp 01/11/24; 1223049792 Exp 01/15/24; 1223049793 Exp 01/15/24; 1223049905 Exp 01/19/24; 1223050029 Exp 1/24/24; 1223050061 Exp 01/25/24; 1223050179 Exp 01/29/24
- Distribution
- Nationwide in the USA
- Quantity
- 5,734 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-0405-2024
-
Class II Terminated
HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 1223049529, Exp 01/03/24
- Distribution
- Nationwide in the USA
- Quantity
- 256 cassettes
- 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-0404-2024
-
Class II Terminated
fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022,
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022,
- Lots / codes
- Lot #: 1223048959, Exp 12/11/23; 1223049009, Exp 12/12/23; 1223049170, Exp 12/20/23; 1223049245, Exp 12/22/23
- Distribution
- Nationwide in the USA
- Quantity
- 500 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-0403-2024
-
Class II Terminated
fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200-17, Bar…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200-17, Bar code 70004020017
- Lots / codes
- Lot #: 1223048522, Exp 12/07/23; 1223049168, Exp 01/04/24; 1223049552, Exp 01/19/24
- Distribution
- Nationwide in the USA
- Quantity
- 1,259 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-0402-2024
-
Class II Terminated
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd.,…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0251-64, Bar Code 70004025164
- Lots / codes
- Lot #: 1223048722, Exp 11/29/23; 1223049096, Exp 12/15/23
- Distribution
- Nationwide in the USA
- Quantity
- 130 cassettes
- 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-0401-2024
-
Class II Terminated
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd.,…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0289-64, Bar Code 70004028964
- Lots / codes
- Lot #: 1223049261, Exp 12/25/23; 1223049724, Exp 01/11/24
- Distribution
- Nationwide in the USA
- Quantity
- 412 cassettes
- 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-0400-2024
-
Class II Terminated
fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122
- Lots / codes
- Lot #: 1223049125, Exp 12/04/23
- Distribution
- Nationwide in the USA
- Quantity
- 324 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-0399-2024
-
Class II Terminated
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd.…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-64, Bar Code 70004023164
- Lots / codes
- Lot #: 1223049754, Exp 01/12/24; 1223049992, Exp 01/23/24; 1223050066, Exp 01/25/24
- Distribution
- Nationwide in the USA
- Quantity
- 613 Cassettes
- 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-0398-2024
-
Class II Terminated
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 0609…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132
- Lots / codes
- Lot #: 1223048855, Exp 12/6/23
- Distribution
- Nationwide in the USA
- Quantity
- 242 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-0397-2024
-
Class II Terminated
fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 1223048351, Exp 11/30/23; 1223048532, Exp 12/07/23
- Distribution
- Nationwide in the USA
- Quantity
- 500 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-0396-2024
-
Class II Terminated
fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 BAR code 70004022940
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 1223045757, Exp 12/27/23; 1223049716, Exp 5/25/24
- Distribution
- Nationwide in the USA
- Quantity
- 548 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-0395-2024
-
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 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
-
Class II Ongoing
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01
Reason: The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Lots, distribution and details
- Lots / codes
- Lot #: 052001, 052003, Exp. Date 11/2024; 023012, 023014, Exp. Date 08/2024
- Distribution
- Nationwide within the United States
- Quantity
- 22,644 ampuls
- Recall started
- March 12, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0392-2024
-
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
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.