fda regulated Recalls

1,264 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DRUG

Boothwyn Pharmacy Semaglutide Injection Recall for Subpotent Drug (4 mL, 2.5 mg/mL)

Boothwyn Pharmacy recalls 648 vials of semaglutide 2.5 mg/mL injection nationwide after detecting subpotent potency. The recall involves products distributed across the U.S. and is classified as Class II with a high hazard level. Stop using the product and contact Boothwyn Pharmacy or a healthcare provider for guidance.

Boothwyn Pharmacy
Subpotent Drug
Read more
Health & Personal Care
HIGH
FDA DRUG

H-E-B inControl Alcohol Pads Recalled for Subpotent Isopropyl Alcohol (2025)

H-E-B and its inControl brand recall 300,000 sterile alcohol pads nationwide after the FDA alerted a subpotent isopropyl alcohol concentration. The pads were packaged in China with components from Taiwan and distributed nationwide. Consumers should stop using the product immediately and seek guidance from healthcare providers or MEDLINE INDUSTRIES, LP.

H-E-B
Subpotent Drug-
Read more
Health & Personal Care
HIGH
FDA DRUG

CURAD Alcohol Prep Pads Recall for Subpotent Isopropyl Alcohol (2025)

CURAD Alcohol Prep Pads recalled nationwide after tests found isopropyl alcohol levels subpotent. Medline Industries is the maker listed on recall documents. The issue concerns diluted potency below labeled concentration. Stop using immediately and contact Medline for guidance.

CURAD
Subpotent Drug-
Read more
Food & Beverages
HIGH
FDA FOOD

Evergreen Orchard Farm Korean Pear Juice Recalled for 610 Cases in 2025

Evergreen Orchard Farm recalled 610 cases of Korean Pear Juice distributed in Pennsylvania, New Jersey and New York after finding a lack of pasteurization and sanitation records. The recall highlights a potential adulteration risk. Consumers who purchased this product should not drink it and should contact Evergreen Orchard Farm for refunds or replacements via email.

Evergreen Orchard Farm
Lack of
Read more
Health & Personal Care
HIGH
FDA DEVICE

Tandem Diabetes Care Recalling 19 Units of t:slim X2 Insulin Pump Over RTL App Defect (2025)

Tandem Diabetes Care recalls 19 units of the t:slim X2 insulin pump with interoperable technology distributed internationally, including Israel. An app defect occurs when the phone uses a right-to-left language and can cause app-pump pairing problems and graphical defects. Patients should stop using the device immediately and follow the manufacturer’s recall instructions.

Tandem Diabetes Care
an app
Read more
Food & Beverages
HIGH
FDA FOOD

Evergreen Orchard Farm Grape Juice Recalled in 78 Cases for 2025 Pasteurization Lapse

Evergreen Orchard Farm recalled 78 cases of Grape Juice in 4 oz foil pouches distributed to PA, NJ and NY. The recall cites lack of pasteurization and sanitation records. Consumers who purchased the product should not consume it and should contact Evergreen Orchard Farm, LLC via Email for refund or replacement.

Evergreen Orchard Farm
Lack of
Read more
Vehicles & Parts
HIGH
NHTSA

Honda 2025 CR-V Hybrid Recall for Fuel Hose Installation Could Cause Fire (TLS)

Honda recalls 2025 CR-V Hybrid vehicles sold through Honda dealers nationwide after finding an improperly installed fuel feed hose that may leak. The recall is identified by Honda as TLS. Dealers will replace the fuel feed hose and install a new connector cover at no charge. Owners should contact Honda at 1-888-234-2138 for service.

Honda
A fuel
Read more
Health & Personal Care
HIGH
FDA DEVICE

bioMerieux VITEK 2 AST Cards Recalled for False Colistin Results (235,269 Cards) 2025

bioMerieux recalled 235,269 VITEK 2 Gram-negative AST test cards containing Colistin cs02n, distributed internationally. The cards may produce false resistant results for Colistin when testing certain multi-drug-resistant bacteria. Healthcare providers should stop using the affected cards immediately and follow the recall instructions from bioMerieux.

bioMerieux
Potential for
Read more
Food & Beverages
HIGH
FDA FOOD

BulkSupplements.com Inositol Recall Affects 1,001 Units Over Possible Staphylococcus Contamination (

BulkSupplements.com recalled 1,001 units of Inositol powder sold in the U.S. and abroad after potential contamination with Staphylococcus aureus. The finished product was distributed by Hard Eight Nutrition LLC dba BulkSupplements.com and classified as a Class II recall. Consumers should stop using the product and seek refunds or replacements from the company.

BulkSupplements.com
Finished product
Read more
Health & Personal Care
HIGH
FDA DEVICE

Orthofix Pillar SA Ti Spinal Implant Recalled for Labeling Error (2025)

Orthofix U.S. recalled 3 Pillar SA Ti intervertebral body fusion devices nationwide in the United States after a labeling discrepancy. The 37 mm implant width is correct on the front label, but the outer side flap and inner label information box incorrectly state 33 mm. Healthcare providers and patients should stop using the device immediately and await manufacturer instructions.

Orthofix U.S.
A 37
Read more
Health & Personal Care
HIGH
FDA DEVICE

Quidel Dipstick Strep A Tests Recalled for Potential False Positives (Z-2545-2025)

Quidel recalls 22,470 Rapid Strep A Dipstick tests sold worldwide, including multiple U.S. states. The dipstick test may yield false positive results. Health providers and patients should stop using the device immediately and follow recall instructions. Check with Quidel for refund or replacement options.

Quidel
Dipstick strep
Read more
Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA SM-40HF-B-D-C Mobile X-ray System Recall for Cleaning Not Water-Resistant Risk (2025)

Sedecal SA recalled 1 mobile X-ray system in the United States. The device is distributed in CA, IL and NJ. The system is not water-resistant and must be cleaned strictly per the manual. Improper cleaning could have unspecified consequences. Clinicians and facilities should stop using the device and follow manufacturer instructions.

Sedecal
Sedecal sent
Read more
Health & Personal Care
HIGH
FDA DEVICE

Sedecal 40KWFX Mobile X-ray System Recall Affects 55 US Units (2025)

Sedecal recalled 55 Mobile X-ray System units sold to facilities in California, Illinois and New Jersey. The devices are not water-resistant and must be cleaned exactly as described in the manual, with clear warnings about the consequences of improper cleaning. Hospitals and healthcare providers should stop using the device immediately and follow Sedecal's recall instructions.

Sedecal
Sedecal sent
Read more
Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA Recalls Shimadzu RF.004 Mobile X-ray System in 2025

Sedecal SA is recalling the Shimadzu RF.004 Mobile X-ray System after warnings that the device is not water-resistant and must be cleaned strictly according to the manual. Hospitals in California, Illinois, and New Jersey are affected. Stop using the device and follow recall instructions.

Sedecal SA
Sedecal sent
Read more
Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA Recalls 4 SM-40HF-B-D-C Mobile X-ray Systems in 2025

Sedecal SA recalled 4 SM-40HF-B-D-C 40KW mobile X-ray systems sold in California, Illinois and New Jersey. A notice warns the equipment is not water-resistant and must be cleaned exactly as described in the manual to avoid possible consequences of improper cleaning. Healthcare providers should stop using the device immediately and contact Sedecal SA or their provider for instructions.

Sedecal SA
Sedecal sent
Read more
Health & Personal Care
HIGH
FDA DEVICE

Sedecal Easy Moving Plus Mobile X-ray System Recalled for Cleaning Not Water-Resistant Risk (8 Units

Sedecal recalled 8 units of the Easy Moving Plus mobile X-ray system distributed in California, Illinois and New Jersey. The devices are not water-resistant and cleaning must follow the manual to avoid the consequences of improper cleaning. Stop using the device and contact Sedecal SA or your healthcare provider for instructions.

Sedecal
Sedecal sent
Read more