State

South Dakota product recalls

72,992 recalls have nationwide distribution and so reach South Dakota. 2,681 additional recalls listed South Dakota specifically in their distribution scope.

What the numbers show

Total: 2,681
Critical: 401
Severe: 565
Most recent: 2026-09-02

Of the 2,681 recalls naming South Dakota we have scored against our rubric, 401 (15%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 565 (21%) are Severe.

Which agencies issued them

These figures cover only the 2,681 recalls whose distribution notice names South Dakota specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8501–8525 of 75673

HighFDA (Devices)·Z-0626-2025·2024-12-11
Medline recalls surgical convenience kits with defective smoke evacuation component
Medline is recalling five types of medical convenience kits because they contain the SafeAir Smoke Evacuation Pencil, which Stryker subsequently recalled.
Product
MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3) MAJOR VASCULAR PACK-LF, REF DYNJ0488546K; 4) PEDS CENTRAL LINE PACK, REF DYNJ84762; 5) PACK,CENTRAL LINE, REF DYNJ906907C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0079-2025·2024-12-11
Cinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding FDA Safety Limit
Aurobindo Pharma USA recalls Cinacalcet 90 mg tablets nationwide due to N-nitroso impurity exceeding FDA's interim safety limit. The impurity is a known carcinogenic compound.
Product
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 658
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0649-2025·2024-12-11
Medline recalls surgical kits containing Stryker smoke evacuation pencil component
Medline is recalling medical convenience kits containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0620-2025·2024-12-11
Olympus Removes Acecide-C Disinfection from GIF-1TH190 Endoscope Reprocessing
Olympus has removed high-level disinfection with Acecide-C as an approved reprocessing method for the GIF-1TH190 gastrointestinal videoscope. Approximately 1,770 units nationwide are affected.
Product
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0080-2025·2024-12-11
Venofer Iron Sucrose Injection Recalled for Potential Glass Contamination
American Regent is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination from vials. The affected drug is distributed nationwide.
Product
VENOFER — VENOFER (IRON SUCROSE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0103-2025·2024-12-11
Prescription Drug Sunitinib Malate Subject to Label Mix-Up Recall
AvKARE is recalling 40 bottles of Sunitinib Malate Capsules due to a label mix-up. The affected lot was distributed nationwide in the United States.
Product
SUNITINIB MALATE — SUNITINIB MALATE (SUNITINIB MALATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0095-2025·2024-12-11
Diltiazem Hydrochloride Extended-Release Capsules Recalled for Manufacturing Impurity
Glenmark Pharmaceuticals is recalling 25,584 bottles of Diltiazem Hydrochloride Extended-Release Capsules 120 mg nationwide due to a manufacturing impurity above FDA-recommended limits. The affected medication was distributed throughout the United States.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0082-2025·2024-12-11
Prescription Drug Recall: Venofer Iron Sucrose Vials with Glass Delamination Risk
American Regent, Inc. is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination in vials. The intravenous drug distributed nationwide may contain particulate matter.
Product
VENOFER — VENOFER (IRON SUCROSE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0091-2025·2024-12-11
Genuine Joe Antibacterial Lotion Soap recalled for manufacturing quality issue
Midlab Incorporated is recalling Genuine Joe Antibacterial Lotion Soap (Lot 0711241) nationwide due to out-of-specification microbial test results found during manufacturing quality checks.
Product
Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0109-2025·2024-12-11
Cinacalcet Tablets Recalled for Elevated Nitrosamine Impurity
AvKARE is recalling 2,396 bottles of Cinacalcet Tablets 60 mg (Lot #44550) distributed nationwide due to CGMP deviations. The tablets contain N-Nitroso-Cinacalcet, a nitrosamine impurity, above acceptable intake limits.
Product
Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0598-2025·2024-12-11
Cartiva Synthetic Cartilage Implants Recalled Due to Higher Complication Rates
Cartiva Synthetic Cartilage Implants are being recalled due to higher-than-expected rates of complications including implant displacement, subsidence, nerve damage, and fragmentation. Patients with these implants should consult their surgeon.
Product
Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0076-2025·2024-12-11
Levothyroxine Sodium Tablets Recalled Due to Subpotency Nationwide
Accord Healthcare is recalling Levothyroxine Sodium 75 mcg tablets (Lot D2300191, expiring 12/31/2025) distributed nationwide due to subpotency. Affected patients should contact their healthcare provider.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0093-2025·2024-12-11
Diltiazem Hydrochloride Capsules Recalled Due to Manufacturing Impurity
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride Extended-Release Capsules (60 mg) due to presence of N-nitroso-Desmethyl-Diltiazem impurity exceeding FDA limits. Approximately 34,848 bottles nationwide are affected.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0589-2025·2024-12-11
BD COR GX Instrument recalled due to compromised service credentials
Becton Dickinson recalls the BD COR GX Instrument due to unauthorized access to product service credentials. Until credentials are updated, there is a risk of unauthorized device access and potential impact to data security.
Product
BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0584-2025·2024-12-11
BD EpiCenter Medical Device Software Service Credentials Accessed by Unauthorized Party
BD EpiCenter software service credentials were accessed by an unauthorized actor. Until credentials are updated, there is risk of unauthorized access to the software and associated data.
Product
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0581-2025·2024-12-11
BIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
Smith & Nephew is recalling BIORAPTOR Suture Anchors due to inadequate packaging design that fails to maintain sterile barriers, potentially contaminating the implant. No injuries or illnesses have been reported.
Product
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0098-2025·2024-12-11
Diltiazem Hydrochloride Capsules Recalled Due to Nitrosamine Impurity
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride capsules because they contain a chemical impurity above safe limits. About 7,296 bottles were distributed nationwide.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0246-2025·2024-12-11
Albertsons Green Chili Chicken Enchiladas Recalled for Listeria Contamination
Albertsons is recalling two green chicken enchilada meal kit products due to Listeria monocytogenes contamination in the cooked chicken. Affected products were distributed across 20 states with sell-through dates up to October 13, 2024.
Product
(1) READY MEALS GREEN CHILI CHICKEN ENCHILADAS SS COLD (UPC 21291600000) (2) GREEN CHICKEN ENCHILADAS 6 CT SS COLD (UPC 27163500000)
Category
Food
Distribution
21 states
HighFDA (Devices)·Z-0629-2025·2024-12-11
MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Pencil Component
MEDLINE is recalling 102 varieties of surgical convenience kits containing SafeAir Smoke Evacuation Pencils that have been recalled by manufacturer Stryker. The nationwide recall affects 24,754 units.
Product
MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T & A,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0643-2025·2024-12-11
MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Component
MEDLINE is recalling surgical convenience kits nationwide because they contain smoke evacuation pencil components from a Stryker product that was previously recalled. The affected kits are used in robotic and laparoscopic surgical procedures.
Product
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN LAP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0097-2025·2024-12-11
Diltiazem extended-release capsules recalled for manufacturing impurity
Glenmark Pharmaceuticals is recalling 4,704 bottles of Diltiazem Hydrochloride extended-release capsules 90mg due to manufacturing contamination with an impurity above FDA limits. Two lot numbers distributed nationwide are affected.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0592-2025·2024-12-11
BD Phoenix M50 Automated Microbiology System Service Credentials Exposed
BD confirmed that service credentials used by technical support teams were accessed by an unauthorized actor, creating a risk of unauthorized access to BD microbiology systems and associated data.
Product
BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0595-2025·2024-12-11
BACTEC 9120 System Recalled Due to Compromised Service Credentials
BD recalled BACTEC 9120 Systems because technical support credentials were compromised by an unauthorized actor. Until credentials are updated, there is a risk of unauthorized access to the devices and associated data.
Product
BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0596-2025·2024-12-11
Medical Device Breach: BACTEC 9240 System Faces Unauthorized Access Risk
Becton Dickinson recalled the BACTEC 9240 System after unauthorized actors accessed product service credentials. Until credentials are updated, there is risk of unauthorized access that may compromise system security and data integrity.
Product
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0090-2025·2024-12-11
ROYALAB Germ Away Antibacterial Hand Soap Recalled for Failed Microbiological Testing
Midlab Incorporated is recalling ROYALAB Germ Away Antibacterial Hand Soap (1-gallon, Lot 0711241) due to out-of-specification microbiological test results. The product failed manufacturing quality standards.
Product
ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139
Category
Drug
Distribution
Distributed nationwide