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Zydus Pharmaceuticals (USA) Recalls
95 recalls on record · August 8, 2012 to August 12, 2026 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, In
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad,
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedab
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad,
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad,
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmeda
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distribut
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
May 15, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed
Hazard: Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
May 15, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by
Hazard: Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
May 1, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distribute
Hazard: Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
December 6, 2017DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC
Hazard: Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
September 20, 2017DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distri
Hazard: Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
August 9, 2017DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (ND
Hazard: Failed Dissolution Specifications
August 9, 2017DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68
Hazard: Failed Dissolution Specifications
August 9, 2017DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd
Hazard: Failed Dissolution Specifications
April 5, 2017DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033
Hazard: Failed Dissolution Specifications; 9 month long term stability
March 29, 2017DrugsFDA
Zydus Pharmaceuticals USA Inc recalls ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC 68382-0
Hazard: Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
December 28, 2016DrugsFDA
Zydus Pharmaceuticals USA Inc recalls BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b)
Hazard: Failed Dissolution Specifications; 6 month time point
November 30, 2016DrugsFDA
Zydus Pharmaceuticals USA Inc recalls BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila
Hazard: Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
September 14, 2016DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad
Hazard: Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
August 24, 2016DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382
Hazard: Failed Dissolution Specifications: out of specification dissolution results in retained samples
August 24, 2016DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 6838
Hazard: Failed Dissolution Specifications: out of specification dissolution results in retained samples
March 2, 2016DrugsFDA
Zydus Pharmaceuticals USA Inc recalls risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmeda
Hazard: Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
December 31, 2014DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Z
Hazard: Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
December 24, 2014DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India;
Hazard: Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
December 10, 2014DrugsFDA
Zydus Pharmaceuticals USA Inc recalls BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, Indi
Hazard: Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
December 3, 2014DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedaba
Hazard: Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
October 22, 2014DrugsFDA
Zydus Pharmaceuticals USA Inc recalls TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distribut
Hazard: Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.