nhtsa regulated Recalls

370 recalls tagged with “nhtsa regulated”.

Health & Personal Care
HIGH
FDA DRUG

Biocon Pharma Prazosin Hydrochloride 5mg Recall 28,157 Bottles Over Nitrosamine Impurity (2026)

Biocon Pharma Inc. recalled 28,157 bottles of PRAZOSIN HYDROCHLORIDE capsules, distributed nationwide in the USA. The recall cites cGMP deviation due to detection of N-nitroso-prazosin impurity C above acceptable limits. Stop using the product immediately and contact Appco Pharma LLC or your healthcare provider for guidance.

Prazosin Hydrochloride
cGMP deviation:
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Health & Personal Care
HIGH
FDA DRUG

Biocon Prazosin Hydrochloride 2 mg Capsules Recalled for Nitrosamine Impurity (58,896 bottles, 2026)

Biocon Pharma Inc. recalled 58,896 bottles of Prazosin Hydrochloride Capsules, USP, 2 mg, 100-count bottle. The product was distributed nationwide in the USA and manufactured by Appco Pharma LLC. A cGMP deviation detected N-nitroso-prazosin impurity C above acceptable limits. Consumers and healthcare providers should stop using this product immediately and contact Appco Pharma LLC or their health‑

Prazosin Hydrochloride
cGMP deviation:
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Health & Personal Care
HIGH
FDA DRUG

Fagron Compounding Services Vancomycin HCl 1 g in 250 mL NS Injection Recall Expands in 2026

Fagron Compounding Services is recalling 11,680 bags of Vancomycin HCl 1 g in 250 mL 0.9% Sodium Chloride Injection. The recall is nationwide in the United States. The blue break-off part could detach from the administration port, raising sterility concerns. Stop using immediately and contact the provider for guidance.

Fagron Compounding Services
Lack of
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Recalled Aisstxoer Adult Bike Helmet (pink)
HIGH
CPSC

Aisstxoer Adult Bicycle Helmets Recalled Over Head Injury Risk (2026)

Aisstxoer adult bicycle helmets sold on Amazon by YXTDZ Store are being recalled. The helmets fail to meet mandatory safety standards for impact attenuation and stability, creating a serious head-injury risk. Stop using the recalled helmet now and contact YXTDZ Store for a full refund; destroy the helmet and email a photo to yxtdzamz@126.com.

Aisstxoer Adult Bicycle Helmets
The recalled
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Health & Personal Care
HIGH
FDA DRUG

Teva Octreotide Acetate Injectable Suspension Recall 21,930 Cartons Over Sterility Risk (2026)

Teva Pharmaceuticals recalled 21,930 cartons of Octreotide Acetate for Injectable Suspension distributed nationwide in the United States. The recall stems from lack of assurance of sterility identified during an FDA inspection at the contract manufacturer. Healthcare providers and patients should stop using this product immediately and contact Teva or a physician for guidance.

OCTREOTIDE ACETATE
Lack of
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Health & Personal Care
HIGH
FDA DRUG

Teva Octreotide Acetate Injectable Suspension Recall 19,869 Cartons Nationwide (2026)

Teva Pharmaceuticals USA recalled 19,869 cartons of Octreotide Acetate for Injectable Suspension nationwide in the United States after FDA inspection flagged lack of assurance of sterility at the contract manufacturer. The FDA cited quality system deficiencies at Pharmathen International S.A. in Greece. Healthcare providers and patients should stop using the product immediately and contact Teva or

OCTREOTIDE ACETATE
Lack of
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Health & Personal Care
HIGH
FDA DRUG

Xanax XR Alprazolam Recall Over Failed Dissolution Specifications Affects US Nationwide Distribution

Xanax XR extended-release alprazolam recall issued March 17, 2026 remains active. Viatris Specialty LLC distributes the drug nationwide in the United States. The issue is failed dissolution specifications. Patients and healthcare providers should stop using the product immediately and follow the recall instructions for guidance.

XANAX
Failed Dissolution
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Health & Personal Care
HIGH
FDA DRUG

Cipla USA Lanreotide Injection Recall for Sterility Assurance Issue (2026)

Cipla USA Inc. recalls 54,583 Lanreotide acetate injections nationwide after FDA flagged sterility assurance concerns at a contract manufacturer. The recall covers a box containing one pre-filled syringe and one safety needle. Healthcare providers and patients should stop using the product immediately and follow the company’s guidance for disposal and refunds.

LANREOTIDE ACETATE
Lack of
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Health & Personal Care
HIGH
FDA DRUG

Fresenius Kabi 5% Dextrose Injection Recall for Sterility Concerns (2026) Affecting US Nationwide, R

Fresenius Kabi USA, LLC recalls 5% Dextrose Injection, USP IV solution in freeflex bags due to lack of assurance of sterility. The recall affects batches 6402399, 6402400, and 6402401 with Exp 02/28/2027. Distributors nationwide, including Alaska and Puerto Rico, are notified. Stop using and contact the company for guidance and potential replacement.

DEXTROSE
Lack of
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Health & Personal Care
HIGH
FDA DEVICE

Siemens ARTIS pheno and ARTIS Icono Imaging Systems Recalled for Dose-Display Anomaly (2026)

Siemens Medical Solutions USA recalled 758 units in the U.S. and 2,077 outside the U.S. of ARTIS pheno and ARTIS Icono imaging systems after a dose-display anomaly could misrepresent high X-ray doses. The devices may still be within regulatory dose limits, but the displayed dose may appear significantly higher. Clinicians should stop using the devices and await manufacturer guidance.

Siemens Medical Solutions USA
During patient
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Health & Personal Care
HIGH
FDA DRUG

Zydus Icosapent Ethyl Capsules Recalled for Oxidized Ingredient in 60,541 Bottles (2026)

Zydus Pharmaceuticals USA Inc. is recalling 60,541 bottles of Icosapent Ethyl Capsules, 1 g, 120 capsules per bottle, distributed nationwide in the United States. The recall cites oxidized Icosapent Ethyl causing red dots inside capsules and melted capsules. Patients should stop using the medicine immediately and contact Zydus Pharmaceuticals USA Inc. or their clinician for guidance.

ICOSAPENT ETHYL
Failed Tablet/Capsule
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