fda regulated Recalls

1,264 recalls tagged with “fda regulated”.

Food & Beverages
HIGH
FDA FOOD

Lipton Green Tea Citrus Recalled for Undeclared Sugar in 2,854 Cases (2025)

PepsiCo's Lipton Green Tea Citrus RTD bottles, sold at multiple retailers, are recalled after undeclared sugar was found in the finished product. A labeling error shows 25g sugar on the outer case while individual bottle labels show 0g. Consumers should not drink this product and should contact PepsiCo for refunds or replacements.

Lipton
Undeclared sugar
Read more
Health & Personal Care
HIGH
FDA DEVICE

CPM Medical Consultants Recalls 3,317 Fuse ULTRA Foot Plating System IFU Updates (2025)

CPM Medical Consultants recalls 3,317 Fuse ULTRA Foot Plating System Instructions for Use issued nationwide in the United States. The recall addresses sterilization steps that are no longer required in the United States. Healthcare providers should stop using the current IFU and follow CPM’s recall instructions.

CPM Medical Consultants
Instructions for
Read more
Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Oral Probe Recalled for 5,209 Units Misconfigured as Rectal Probes (2025)

Baxter Healthcare recalled 5,209 oral/axillary probes used with Welch Allyn SureTemp Plus thermometers nationwide in the United States, Canada and Colombia. The probes were inadvertently programmed with the rectal configuration, which can yield a lower temperature reading. Healthcare providers and patients should stop using the affected probes immediately and follow Baxter’s recall instructions.

Baxter Healthcare
Affected oral/axillary
Read more
Health & Personal Care
HIGH
FDA DRUG

Accord Healthcare Recalls 54,432 Levothyroxine 88 mcg Tablets for Subpotent Potency (2025)

Accord Healthcare recalled 54,432 bottles of Levothyroxine Sodium Tablets, USP, 88 mcg, distributed nationwide in the United States. The recall is due to subpotent assay content observed during long-term stability testing. Patients should stop using the product immediately and contact Accord Healthcare or their healthcare provider for guidance.

Levothyroxine Sodium
Subpotent: During
Read more
Food & Beverages
HIGH
FDA FOOD

Lawrence Wholesale Shrimp Cocktail Bowls Recalled for Cs-137 Contamination Risk (2025)

Lawrence Wholesale recalled 8,400 cases of Shrimp Cocktail Bowl products sold to Kroger stores in 15 states on Sept. 16, 2025 due to potential Cesium-137 contamination. The recall involves 7oz and 17oz clear plastic bowls with UPCs 011110622952 and 011110624840. Consumers should not consume the product and should contact Lawrence Wholesale LLC for refund or replacement by email.

Lawrence Wholesale
Product manufactured
Read more
Health & Personal Care
HIGH
FDA DRUG

IntegraDose Oxytocin IV Solution Recall 2025 for Subpotent Drug, 853 Bags Nationwide

IntegraDose Compounding Services recalled 853 IV bags of Oxytocin 30 Units/500 mL in 0.9% sodium chloride. The recall is nationwide in the United States. Testing found no oxytocin in the IV bags. Stop using the product and contact IntegraDose or a healthcare provider for guidance.

IntegraDose Compounding Services
Subpotent Drug:
Read more
Food & Beverages
HIGH
FDA FOOD

Lawrence Wholesale Frozen Shrimp Recalled for Cs-137 Contamination (4,871 Cases, 2025)

Lawrence Wholesale recalled 4,871 cases of frozen tail-on shrimp sold through Kroger stores in 16 states. The products were manufactured under insanitary conditions and may be contaminated with Cesium-137. Consumers should not eat these shrimp and should contact Lawrence Wholesale LLC for refunds or replacements.

Lawrence Wholesale
Product manufactured
Read more
Health & Personal Care
HIGH
FDA DEVICE

Alcon CONSTELLATION Ultravit 10K & HyperVit 20K Recall for 28,323 Units (2025)

Alcon recalls 28,323 CONSTELLATION Ultravit 10K and CONSTELLATION HyperVit 20K devices used in hospitals worldwide. The recall lists an unspecified hazard. Hospitals should stop using the devices immediately and follow the manufacturer’s instructions. Access the FDA recall notice for details.

Alcon
XXX
Read more
Health & Personal Care
HIGH
FDA DEVICE

FUJIFILM Healthcare CH-200 Recalled for Broken X-ray Tube Shaft in 16 Units

FUJIFILM Healthcare Americas Corp recalled 16 CH-200 X-ray machines in the domestic market. The shaft that mounts the X-ray tube unit on the support may break. Protective parts may fail when the shaft breaks during frontward lifting. Healthcare providers should stop using the device immediately and follow recall instructions.

FUJIFILM Healthcare
It was
Read more
Health & Personal Care
HIGH
FDA DRUG

Graviti Pharmaceuticals Bupropion Hydrochloride XL 300 mg Recall Impacts 46,512 Bottles (2025)

Graviti Pharmaceuticals Private Limited manufactured Bupropion Hydrochloride Extended-Release Tablets XL 300 mg, distributed nationwide by Rising Pharma Holdings, Inc., in 46,512 bottles. The recall cites failed tablet specifications. Stop using the product immediately and contact the manufacturer or your healthcare provider for guidance.

Bupropion Hydrochloride
Failed Tablet/Capsule
Read more
Health & Personal Care
HIGH
FDA DRUG

Private Label Skin Care Inc. Benzoyl Peroxide 10% Acne Treatment Recalled for Benzene Contamination

A benzoyl peroxide acne treatment sold under mel rx Skin by Private Label Skin Care Inc. is recalled for benzene contamination. The recall covers Lot #58170A and 58172A with expiration date 09/2025 and distribution limited to California and Georgia. Consumers should stop using the product immediately and contact the company for guidance.

Private Label Skin Care
Chemical Contamination:
Read more
Health & Personal Care
HIGH
FDA DRUG

Skin MD Body Acne Cleanser Recalled for Elevated Benzene Levels (2025)

Skin MD by Dr Monika Kiripolsky recalled its Body Acne Cleanser after detecting elevated benzene levels. The recall covers products associated with Lot # 58170A and Lot # 58172A distributed in CA and GA. Consumers should stop use and seek guidance from a healthcare provider.

Skin MD
Chemical Contamination:
Read more
Health & Personal Care
HIGH
FDA DEVICE

UIH Technologies Recalls 2 uCT ATLAS MD CT X-ray Systems for Mechanical Interference Risk (2025)

UIH Technologies LLC recalled 2 units of the uCT ATLAS MD CT X-ray System sold to U.S. health care providers after reports of potential mechanical interference during table movement. The issue involves third-party outer covers that can become trapped between the patient table and gantry. Hospitals should stop using the devices immediately and follow recall instructions from UIH Technologies LLC.

UIH Technologies
Third-party outer
Read more
Food & Beverages
HIGH
FDA FOOD

M.O.M Enterprises Recalls 46,752 Organic BABY Bedtime Drops Over Yeast Contamination (2025)

M.O.M Enterprises recalled 46,752 bottles of Organic BABY bedtime drops sold nationwide through Unknown retailers after FDA enforcement notice flagged potential yeast contamination. The product is a liquid dietary supplement for infants age 4 months and older. Parents should stop using the product immediately and contact M.O.M Enterprises for refund or replacement.

M.O.M Enterprises
Potential yeast
Read more
Health & Personal Care
HIGH
FDA DEVICE

Diagnostica Stago STA Liatest D-Di Recall 12,740 Units Worldwide in 2025

Diagnostica Stago recalled 12,740 STA Liatest D-Di units distributed worldwide after a potential risk of underestimating D-Dimer levels. The two listed lots may produce falsely low results. Stop using the devices immediately and follow recall instructions from Diagnostica Stago or your healthcare provider.

Diagnostica Stago
A potential
Read more
Health & Personal Care
HIGH
FDA DEVICE

GE HealthCare Recalls 28 Elscint SPX6 Gamma Cameras Worldwide in 2025

GE HealthCare is recalling 28 Elscint SPX6 dual-head gamma cameras worldwide. The recall cites detectors could be stressed during transport or relocation without adequate detector support, risking a detector fall and life-threatening injury. Hospitals should stop using the devices and follow the manufacturer’s recall instructions.

GE HealthCare
GE HealthCare
Read more