PlainRecalls

Zydus Pharmaceuticals USA Inc

Compiled from official public sources by the editorial team.

94 recalls on record · Latest: May 27, 2026

Zydus Pharmaceuticals USA Inc Recall Insight

Zydus Pharmaceuticals USA Inc appears on 94 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.092% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated May 27, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 44 entries, severity tagging shows 1 critical, 37 moderate, and 6 lower-severity recalls. Affected-unit counts are disclosed on 44 of 44 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 2 distinct product categories, with issuing agencies dominated by FDA Drug (44). The date window on this page runs from Aug 8, 2012 to Dec 23, 2020.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Drug Moderate Dec 23, 2020

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by: Cadila Hea…

FDA Drug Moderate Nov 11, 2020

Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Lt…

FDA Drug Moderate Nov 11, 2020

Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Lt…

FDA Drug Moderate Feb 19, 2020

Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distribute…

FDA Drug Moderate Jun 26, 2019

MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01

FDA Drug Moderate Jun 26, 2019

Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus …

FDA Drug Moderate Jun 26, 2019

Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmac…

FDA Drug Moderate Jun 26, 2019

MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11

FDA Drug Moderate Jun 26, 2019

MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18

FDA Drug Moderate Jun 26, 2019

Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus P…

FDA Drug Moderate Jun 26, 2019

MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Penningt…

FDA Drug Moderate Jun 26, 2019

Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus…

FDA Drug Moderate Jun 26, 2019

Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus …

FDA Drug Moderate Jun 26, 2019

ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals …

FDA Drug Moderate Jun 26, 2019

Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Z…

FDA Drug Moderate Jun 26, 2019

Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10

FDA Drug Moderate Jun 26, 2019

MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11

FDA Drug Moderate Jun 26, 2019

Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pha…

FDA Drug Moderate May 15, 2019

Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA)…

FDA Drug Moderate May 15, 2019

Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (US…

FDA Drug Low May 1, 2019

Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (…

FDA Drug Moderate Dec 6, 2017

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 bottles,…

FDA Drug Moderate Sep 20, 2017

Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceutica…

FDA Drug Moderate Aug 9, 2017

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, Manufact…

FDA Drug Moderate Aug 9, 2017

Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distribut…

FDA Drug Moderate Aug 9, 2017

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 only, man…

FDA Drug Moderate Apr 5, 2017

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 only, manufa…

FDA Drug Moderate Mar 29, 2017

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, Manufactured…

FDA Drug Low Dec 28, 2016

BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-…

FDA Drug Low Nov 30, 2016

BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, In…

FDA Drug Moderate Sep 14, 2016

Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus…

FDA Drug Moderate Aug 24, 2016

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) 1000-count …

FDA Drug Moderate Aug 24, 2016

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) 1000-count b…

FDA Drug Low Mar 2, 2016

risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: …

FDA Drug Moderate Dec 31, 2014

Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In,…

FDA Drug Moderate Dec 24, 2014

Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharma…

FDA Drug Low Dec 10, 2014

BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Phar…

FDA Drug Low Dec 3, 2014

Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zyd…

FDA Drug Moderate Oct 22, 2014

TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals …

FDA Drug Moderate Oct 15, 2014

ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Phar…

FDA Drug Moderate May 28, 2014

PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus…

FDA Drug Critical Aug 14, 2013

Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydu…

FDA Drug Moderate Apr 3, 2013

Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distribu…

FDA Drug Moderate Aug 8, 2012

Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Dis…

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.