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Independent register of U.S. FDA drug recalls · updated Oct 10, 2026

FDA Drug Recalls

1,590 recalls, newest first

Apr 11, 2018 Class II · Moderate risk

Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile…

Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

Terminated Sterility / contamination Premier Pharmacy Labs Inc NDC 69623-249-10 D-0701-2018

Apr 11, 2018 Class II · Moderate risk

Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile…

Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

Terminated Sterility / contamination Premier Pharmacy Labs Inc NDC 69623-127-10 D-0700-2018

Apr 11, 2018 Class II · Moderate risk

Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile…

Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

Terminated Sterility / contamination Premier Pharmacy Labs Inc NDC 69623-129-10 D-0699-2018

Apr 10, 2018 Class II · Moderate risk

Kit for the Preparation of Technetium TC-99M Mebrofenin

Failed Stability Specifications

Terminated Stability / shelf life Pharmalucence, Inc. NDC 45567-0455-1 D-0815-2018

Apr 10, 2018 Class III · Low risk

Ferrous Sulfate 325 MG tablet

Presence of Foreign Tablets/Capsules

Terminated Particulate / foreign matter Aidarex Pharmaceuticals LLC NDC 33261-0715-00 D-0810-2018

Apr 10, 2018 Class III · Low risk

Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP

cGMP deviations

Terminated cGMP deviation Pharmedium Services, LLC D-0632-2018

Apr 9, 2018 Class III · Low risk

Cystaran (cysteamine ophthalmic solution)

Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.

Terminated Wrong potency / content Leadiant Biosciences, INC NDC 54482-020-01 D-0683-2018

Apr 9, 2018 Class II · Moderate risk

Daytrana (methylphenidate transdermal system)

Defective Delivery System: Out of specification for adhesive transfer.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5552-3 D-0627-2018

Apr 6, 2018 Class III · Low risk

Triamterene and Hydrochlorothiazide Tablets

Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).

Terminated Cross-contamination Sandoz Incorporated NDC 0781-5067-05 D-0631-2018

Apr 5, 2018 Class II · Moderate risk

PYRIDOXINE Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.

Presence of Particulate matter. Recall due to presence of unknown particulate matter.

Terminated Particulate / foreign matter Coastal Meds, LLC. D-0726-2018

Apr 5, 2018 Class II · Moderate risk

METHYLCOBALAMIN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.

Presence of Particulate matter. Recall due to presence of unknown particulate matter.

Terminated Particulate / foreign matter Coastal Meds, LLC. D-0725-2018

Apr 5, 2018 Class II · Moderate risk

LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.

Presence of Particulate matter. Recall due to presence of unknown particulate matter.

Terminated Particulate / foreign matter Coastal Meds, LLC. D-0724-2018

Apr 5, 2018 Class II · Moderate risk

LIPO-DEN PLUS Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.

Presence of Particulate matter. Recall due to presence of unknown particulate matter.

Terminated Particulate / foreign matter Coastal Meds, LLC. D-0723-2018

Apr 5, 2018 Class II · Moderate risk

LIPO-DEN EXTREME Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.

Presence of Particulate matter. Recall due to presence of unknown particulate matter.

Terminated Particulate / foreign matter Coastal Meds, LLC. D-0722-2018

Apr 5, 2018 Class II · Moderate risk

LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.

Presence of Particulate matter. Recall due to presence of unknown particulate matter.

Terminated Particulate / foreign matter Coastal Meds, LLC. D-0721-2018

Apr 5, 2018 Class II · Moderate risk

LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.

Presence of Particulate matter. Recall due to presence of unknown particulate matter.

Terminated Particulate / foreign matter Coastal Meds, LLC. D-0720-2018

Apr 5, 2018 Class II · Moderate risk

HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr.

Presence of Particulate matter. Recall due to presence of unknown particulate matter.

Terminated Particulate / foreign matter Coastal Meds, LLC. D-0719-2018

Apr 5, 2018 Class II · Moderate risk

ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr.

Presence of Particulate matter. Recall due to presence of unknown particulate matter.

Terminated Particulate / foreign matter Coastal Meds, LLC. D-0718-2018

Apr 5, 2018 Class II · Moderate risk

CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr.

Presence of Particulate matter. Recall due to presence of unknown particulate matter.

Terminated Particulate / foreign matter Coastal Meds, LLC. D-0717-2018

Apr 3, 2018 Class II · Moderate risk

Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply

Lack of Processing Controls.

Terminated cGMP deviation Kroger Specialty Pharmacy, Inc. NDC 00074-3346-03 D-0800-2018

Apr 3, 2018 Class II · Moderate risk

Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply

Lack of Processing Controls.

Terminated cGMP deviation Kroger Specialty Pharmacy, Inc. NDC 00078-0874-63 D-0799-2018

Apr 3, 2018 Class II · Moderate risk

OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply

Lack of Processing Controls.

Terminated cGMP deviation Kroger Specialty Pharmacy, Inc. NDC 00003-3772-11 D-0798-2018

Apr 3, 2018 Class II · Moderate risk

Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply

Lack of Processing Controls.

Terminated cGMP deviation Kroger Specialty Pharmacy, Inc. NDC 00078-0592-87 D-0797-2018

Apr 3, 2018 Class II · Moderate risk

Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply

Lack of Processing Controls.

Terminated cGMP deviation Kroger Specialty Pharmacy, Inc. D-0796-2018

Apr 3, 2018 Class II · Moderate risk

Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply

Lack of Processing Controls.

Terminated cGMP deviation Kroger Specialty Pharmacy, Inc. D-0795-2018

Recalls by year

2026563
2025778
2024557
20231,122
20221,390
20211,152
2020930
20191,788
20181,681
20171,141
20161,199
20151,733
20141,309
20132,085
2012534
201134
20104
20072
20061