Zydus Pharmaceuticals Usa recalls

Zydus Pharmaceuticals Usa appears in 95 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cad…
  FDA Drug · Class II · 2020-12-23 · Zydus Pharmaceuticals Usa
  Reason: Failed Dissolution Specifications
• Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by:…
  FDA Drug · Class II · 2020-12-23 · Zydus Pharmaceuticals Usa
  Reason: Failed Dissolution Specifications
• Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Hea…
  FDA Drug · Class II · 2020-11-11 · Zydus Pharmaceuticals Usa
  Reason: Failed Dissolution Specification
• Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Hea…
  FDA Drug · Class II · 2020-11-11 · Zydus Pharmaceuticals Usa
  Reason: Failed Dissolution Specification
• Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India,…
  FDA Drug · Class II · 2020-02-19 · Zydus Pharmaceuticals Usa
  Reason: cGMP Deviations
• Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India
  FDA Drug · Class II · 2019-06-26 · Zydus Pharmaceuticals Usa
  Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
• Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distrib…
  FDA Drug · Class II · 2019-06-26 · Zydus Pharmaceuticals Usa
  Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
• MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc
  FDA Drug · Class II · 2019-06-26 · Zydus Pharmaceuticals Usa
  Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
• Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed b…
  FDA Drug · Class II · 2019-06-26 · Zydus Pharmaceuticals Usa
  Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
• MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd
  FDA Drug · Class II · 2019-06-26 · Zydus Pharmaceuticals Usa
  Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
• MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd
  FDA Drug · Class II · 2019-06-26 · Zydus Pharmaceuticals Usa
  Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
• Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd
  FDA Drug · Class II · 2019-06-26 · Zydus Pharmaceuticals Usa
  Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
• MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd
  FDA Drug · Class II · 2019-06-26 · Zydus Pharmaceuticals Usa
  Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
• Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd
  FDA Drug · Class II · 2019-06-26 · Zydus Pharmaceuticals Usa
  Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
• Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd
  FDA Drug · Class II · 2019-06-26 · Zydus Pharmaceuticals Usa
  Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
• MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01
  FDA Drug · Class II · 2019-06-26 · Zydus Pharmaceuticals Usa
  Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
• ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd
  FDA Drug · Class II · 2019-06-26 · Zydus Pharmaceuticals Usa
  Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
• Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by:…
  FDA Drug · Class II · 2019-06-26 · Zydus Pharmaceuticals Usa
  Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
• Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd
  FDA Drug · Class II · 2019-06-26 · Zydus Pharmaceuticals Usa
  Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
• Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceu…
  FDA Drug · Class II · 2019-05-15 · Zydus Pharmaceuticals Usa
  Reason: Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
• Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuti…
  FDA Drug · Class II · 2019-05-15 · Zydus Pharmaceuticals Usa
  Reason: Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
• Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India
  FDA Drug · Class III · 2019-05-01 · Zydus Pharmaceuticals Usa
  Reason: 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…
• Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count…
  FDA Drug · Class II · 2017-12-06 · Zydus Pharmaceuticals Usa
  Reason: Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
• Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pha…
  FDA Drug · Class II · 2017-09-20 · Zydus Pharmaceuticals Usa
  Reason: Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
• Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx…
  FDA Drug · Class II · 2017-08-09 · Zydus Pharmaceuticals Usa
  Reason: Failed Dissolution Specifications
• Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only…
  FDA Drug · Class II · 2017-08-09 · Zydus Pharmaceuticals Usa
  Reason: Failed Dissolution Specifications
• Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India,…
  FDA Drug · Class II · 2017-08-09 · Zydus Pharmaceuticals Usa
  Reason: Failed Dissolution Specifications
• Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx onl…
  FDA Drug · Class II · 2017-04-05 · Zydus Pharmaceuticals Usa
  Reason: Failed Dissolution Specifications; 9 month long term stability
• ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC 68382-023-10), Rx only, Ma…
  FDA Drug · Class II · 2017-03-29 · Zydus Pharmaceuticals Usa
  Reason: Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
• BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (ND…
  FDA Drug · Class III · 2016-12-28 · Zydus Pharmaceuticals Usa
  Reason: Failed Dissolution Specifications; 6 month time point
• BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd
  FDA Drug · Class III · 2016-11-30 · Zydus Pharmaceuticals Usa
  Reason: Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
• Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed…
  FDA Drug · Class II · 2016-09-14 · Zydus Pharmaceuticals Usa
  Reason: 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.
• Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16), and c) 10…
  FDA Drug · Class II · 2016-08-24 · Zydus Pharmaceuticals Usa
  Reason: Failed Dissolution Specifications: out of specification dissolution results in retained samples
• Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1…
  FDA Drug · Class II · 2016-08-24 · Zydus Pharmaceuticals Usa
  Reason: Failed Dissolution Specifications: out of specification dissolution results in retained samples
• risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only
  FDA Drug · Class III · 2016-03-02 · Zydus Pharmaceuticals Usa
  Reason: Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
• Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India
  FDA Drug · Class II · 2014-12-31 · Zydus Pharmaceuticals Usa
  Reason: Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
• Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India
  FDA Drug · Class II · 2014-12-24 · Zydus Pharmaceuticals Usa
  Reason: Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
• BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only
  FDA Drug · Class III · 2014-12-10 · Zydus Pharmaceuticals Usa
  Reason: Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
• Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd
  FDA Drug · Class III · 2014-12-03 · Zydus Pharmaceuticals Usa
  Reason: Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
• TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only
  FDA Drug · Class II · 2014-10-22 · Zydus Pharmaceuticals Usa
  Reason: Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
• ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd
  FDA Drug · Class II · 2014-10-15 · Zydus Pharmaceuticals Usa
  Reason: Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
• PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only
  FDA Drug · Class II · 2014-05-28 · Zydus Pharmaceuticals Usa
  Reason: Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
• Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed b…
  FDA Drug · Class I · 2013-08-14 · Zydus Pharmaceuticals Usa
  Reason: Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
• Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India
  FDA Drug · Class II · 2013-04-03 · Zydus Pharmaceuticals Usa
  Reason: Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
• Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, I…
  FDA Drug · Class II · 2012-08-08 · Zydus Pharmaceuticals Usa
  Reason: Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was ob…