Aurobindo Pharma USA Inc recalls Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East…
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Read the official notice →- Date
- 2024-12-25
- Country
- United States
- Brand
- Aurobindo Pharma
- Product
- Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East…
- Classification
- Class II
- Units
- Nationwide in the USA
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Aurobindo Pharma recalls
- 2026-10-07
US
Aurobindo Pharma USA Inc recalls amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N.,…
Discoloration: consumer complaints received for discolored tablets
- 2026-08-12
US
- 2025-06-25
US
Aurobindo Pharma USA Inc recalls Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC…
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
- 2024-12-11
US
Aurobindo Pharma USA Inc recalls Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only,…
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- 2024-08-28
US
Aurobindo Pharma USA Inc recalls Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by:…
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
- 2024-05-15
US
Aurobindo Pharma USA Inc. recalls Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC…
Discoloration: Dotted and yellow spots on tablets
Other drugs & medical recalls in the United States
- 2024-12-25
US
US
Apothecus Pharmaceutical Corp. recalls VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus…
CGMP deviations: out of specifications for assay
FDA · DrugApothecus Pharmaceutical Corp.Nationwide in the USA and 2 Distributors in Hong KongOfficial notice →US
US
Keystone Industries recalls Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd.,…
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was…
FDA · DrugKeystone IndustriesNationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras,…Official notice →- 2024-12-18
US
Noah Medical recalls Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive…
FDA · DeviceNoah MedicalUS Nationwide Distribution: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ,…Official notice →US
Hermes Medical Solutions AB recalls Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
FDA · DeviceHermes Medical Solutions ABU.S.: CA, CT, FL, HI, KY, MA, MD, MO, NJ. NY, OH, TN, TX, VA, and WA O.U.S.:…Official notice →