Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India,…
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Read the official notice →- Date
- 2025-10-08
- Country
- United States
- Brand
- Zydus Pharmaceuticals
- Product
- Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by:…
- Classification
- Class II
- Units
- Distributed 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Zydus Pharmaceuticals recalls
- 2026-01-07
USZydus Pharmaceuticals (USA) Inc recalls traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India,…
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
- 2025-11-26
- US
Zydus Pharmaceuticals (USA) Inc recalls Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd.,…
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
- 2025-11-12
- US
Zydus Pharmaceuticals (USA) Inc recalls clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC…
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
- 2025-09-24
- US
Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by:…
Failed Impurity/Degradation Specifications
- 2025-09-17
- US
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi,…
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- US
Zydus Pharmaceuticals (USA) Inc recalls Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by…
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Other drugs & medical recalls in the United States
- 2025-10-08
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842,…
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice → - US
Apotex Corp. recalls Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc.,…
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
- US
- 2025-10-01
- US
Maquet Cardiovascular, LLC recalls Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH)…
Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft,…
FDA · DeviceMaquet Cardiovascular, LLCUS Nationwide distribution in the states of FL, IL, MD & TX.Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638,…
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice → - US
Mindray DS USA, Inc. dba Mindray North America recalls BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011,…
Potential for activation of an abnormal alarm pause.
FDA · DeviceMindray DS USA, Inc. dba Mindray North AmericaWorldwide - Nationwide distribution and the country of Canada.Official notice →