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Aspen Biopharma Labs Pvt., Ltd.

Aspen Biopharma Labs Pvt., Ltd. Recalls

All product recalls associated with Aspen Biopharma Labs Pvt., Ltd..

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Recall Summary

Total Recalls

1000

Past Year

295

Class I (Serious)

116

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 241–260 of 4465 recalls

Bimatoprost (Aspen Biopharma) – CGMP Deviation (2025)

CGMP Deviations

Class IIModerate

FDAFeb 7, 2025FL, IN• Aspen Biopharma Labs Pvt., Ltd.

Alprostadil (Aspen Biopharma) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAFeb 7, 2025FL, IN• Aspen Biopharma Labs Pvt., Ltd.

Bobcat AirFX Mower Deck (Doosan) – Crushing Hazard (2025)

This recall involves Bobcat & Steiner AirFX Finish Mower Deck attachments. The mower decks are all black and labeled with "AirFX" and either "72" or "61" depending on the mower deck model. The following model numbers, located on the rear of the attachment on the right-side frame rail, are included in this recall. Model Number Description 7526575 72" AirFX 7526579 61" AirFX 7449223 61" AirFx Finish Mower 7447341 72" AirFx Finish Mower

1...11 121314 15...224

Page 13 of 224Next

CPSCFeb 6, 2025Nationwide• Doosan Bobcat North America, of West Fargo, North Dakota

Rotarex Atherectomy System (Bard) – catheter breakage (2025)

Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.

FDAFeb 5, 2025Nationwide• Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438

SIGNA MR380 MRI System (GE Healthcare) – SAR monitoring (2025)

For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.

FDAJan 31, 2025Nationwide• GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China

Potassium Chloride Tablets (Harvard Drug) – Dissolution Failure (2025)

Failed Dissolution Specifications.

Class IIModerate

FDAJan 30, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Leica CM1950 Cryostat (Leica) – firmware data loss (2025)

Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.

FDAJan 30, 2025Nationwide• LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany

Pre-Blend (Bridgewell Agribusiness) – Foreign Material (2025)

Foreign material appears to be white nylon or other plastic thread was found in product.

Class IIModerate

FDAJan 23, 2025IN, NY• Bridgewell Agribusiness LLC

Lorazepam Tablets 1mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Lorazepam Tablets 0.5mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Lorazepam Tablets 2mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

RayStation Planning System (RaySearch) – density uncertainty (2025)

Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

FDAJan 16, 2025Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden