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Zydus Pharmaceuticals (USA) Inc recalls

Every recall we track for Zydus Pharmaceuticals (USA) Inc — 96 in all, from 2012–2026 — plus the complaints and injury reports the public filed about them. 4 are rated “stop using now”.

96recalls
1,260complaints & reports
750injuries reported
120deaths reported

Recalls per year, by danger level

Recalls from Zydus Pharmaceuticals (USA) Inc more than tripled in 2025 (28, up from 9 in 2024). 1% rated “stop using now”.

2017: 7 recalls — 4 lower risk, 3 not yet rated720172018: 0 recalls20182019: 17 recalls — 1 use caution, 7 lower risk, 9 not yet rated1720192020: 5 recalls — 2 lower risk, 3 not yet rated520202021: 3 recalls — 3 lower risk320212022: 1 recall — 1 not yet rated120222023: 5 recalls — 4 lower risk, 1 not yet rated520232024: 9 recalls — 1 stop using now, 1 use caution, 5 lower risk, 2 not yet rated920242025: 28 recalls — 2 use caution, 10 lower risk, 16 not yet rated2820252026 (to date): 5 recalls — 2 use caution, 3 not yet rated52026to date

All FDA recall records for Zydus Pharmaceuticals (USA) Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.

Recalls per year for Zydus Pharmaceuticals (USA) Inc, by danger level
YearStop using nowUse cautionLower riskNot yet ratedTotal
201700437
201800000
2019017917
202000235
202100303
202200011
202300415
202411529
202502101628
2026 (to date)02035

Zydus Pharmaceuticals (USA) Inc recalls before 2017

Recalls on record by year.

  • 20166
  • 20147
  • 20132
  • 20121

Most common reasons for Zydus Pharmaceuticals (USA) Inc recalls

  • Failed Dissolution Specifications6
  • Failed Impurities/Degradation Specifications3
  • Failed Impurities/Degradation Specifications.3
  • Cross contamination with other products2
  • Cross contamination with other products.2

What to do if you have a recalled Zydus Pharmaceuticals (USA) Inc product

  1. Match the NDC and lot number on your bottle or box to the recall.
  2. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
  3. Report side effects to FDA MedWatch.

See this week’s new recalls.

All Zydus Pharmaceuticals (USA) Inc recalls

55 shown

Zydus Pharmaceuticals (USA) Inc recall questions

How many recalls has Zydus Pharmaceuticals (USA) Inc had?

96 recalls from Zydus Pharmaceuticals (USA) Inc are on record with U.S. safety agencies, from 2012–2026.

What is the most recent Zydus Pharmaceuticals (USA) Inc recall?

Zydus Pharmaceuticals (USA) Inc recalls Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences, dated Oct 1, 2026. Every Zydus Pharmaceuticals (USA) Inc recall is listed on this page, newest first.

Why are Zydus Pharmaceuticals (USA) Inc products recalled?

The most common reasons on record: Failed Dissolution Specifications (6); Failed Impurities/Degradation Specifications (3); Failed Impurities/Degradation Specifications. (3); Cross contamination with other products (2).

What should I do if I have a recalled Zydus Pharmaceuticals (USA) Inc product?

Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.

How do I get alerts for new Zydus Pharmaceuticals (USA) Inc recalls?

Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.