Brand recall history

Zydus Pharmaceuticals USA recalls

Every FDA recall record we found for Zydus Pharmaceuticals USA, newest first. Updated Oct. 11, 2026.

24 recalls since 2012. The most recent was on Feb. 19, 2020.

Last 12 months: 0
Most recent: 2020-02
Most serious (FDA Class I): 1
Last 30 days: 0

Recalls by year

2012–2026

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Class I (FDA, most serious)Other recalls

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All recalls

Feb. 19, 2020Ethacrynate Sodium for Injection… Class IIcGMP Deviations
June 26, 2019ANASTROZOLE Tablets… and 13 more products Class IICGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
May 15, 2019Acyclovir Tablets… and 1 more product Class IILabeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
May 1, 2019Carvedilol Tablets… Class IIIPresence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another…
Dec. 6, 2017Paroxetine Tablets USP… Class IIPresence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Sept. 20, 2017Paroxetine tablets USP… Class IIPresence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Aug. 9, 2017Divalproex Sodium Delayed Release Tablets… and 2 more products Class IIFailed Dissolution Specifications
April 5, 2017Divalproex Sodium Delayed Release Tablets… Class IIFailed Dissolution Specifications; 9 month long term stability
March 29, 2017ATENOLOL Tablets… Class IIPresence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Dec. 28, 2016BuPROPion Hydrochloride Extended-Release Tablets (XL)… Class IIIFailed Dissolution Specifications; 6 month time point
Nov. 30, 2016BuPROPion Hydrochloride Extended-Release Tablets… Class IIIFailed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Sept. 14, 2016Bromocriptine Mesylate Capsules USP… Class IIFailed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term…
Aug. 24, 2016Venlafaxine HCL ER Capsule USP… and 1 more product Class IIFailed Dissolution Specifications: out of specification dissolution results in retained samples
March 2, 2016risperiDONE ORALLY DISINTEGRATING TABLETS… Class IIIFailed Impurities/Degradation Specifications: Out of specification for a known degradant.
Dec. 31, 2014Benzonatate Capsules… Class IIFailed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Dec. 24, 2014Benzonatate Capsules… Class IIFailed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Dec. 10, 2014BENZONATATE Capsules… Class IIIPresence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
Dec. 3, 2014Amlodipine Besylate Tablets… Class IIIDiscoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Oct. 22, 2014TOPIRAMATE Tablets 200 mg… Class IIPresence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Oct. 15, 2014ZyGenerics ATENOLOL Tablets… Class IISuperpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
May 28, 2014PROMETHAZINE HYDROCHLORIDE Tablets… Class IIPresence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Aug. 14, 2013Warfarin Sodium Tablets… Class IFailed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were…
April 3, 2013Venlafaxine Hydrochloride Tablets… Class IIFailed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
Aug. 8, 2012Metformin Hydrochloride Tablets… Class IIPresence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The…

How we match: a recall is listed here when the agency names Zydus Pharmaceuticals USA as the company that filed it. Sources: FDA enforcement reports and FDA-posted company announcements, CPSC recall notices and NHTSA recall campaigns.

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