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Lupin Pharmaceuticals Inc. recalls

Every recall we track for Lupin Pharmaceuticals Inc. — 123 in all, from 2013–2026 — plus the complaints and injury reports the public filed about them. 4 are rated “stop using now”.

123recalls
1,625complaints & reports
879injuries reported
145deaths reported

Recalls per year, by danger level

Recalls from Lupin Pharmaceuticals Inc. fell by more than half in 2025 (6, down from 14 in 2024). 4% rated “stop using now”.

2017: 3 recalls — 1 lower risk, 2 not yet rated320172018: 10 recalls — 1 stop using now, 3 use caution, 3 lower risk, 3 not yet rated1020182019: 23 recalls — 17 lower risk, 6 not yet rated2320192020: 17 recalls — 1 use caution, 12 lower risk, 4 not yet rated1720202021: 13 recalls — 2 stop using now, 2 use caution, 4 lower risk, 5 not yet rated1320212022: 13 recalls — 1 stop using now, 3 lower risk, 9 not yet rated1320222023: 5 recalls — 4 lower risk, 1 not yet rated520232024: 14 recalls — 2 use caution, 8 lower risk, 4 not yet rated1420242025: 6 recalls — 2 lower risk, 4 not yet rated620252026 (to date): 4 recalls — 1 use caution, 3 lower risk42026to date

All FDA recall records for Lupin Pharmaceuticals 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 Lupin Pharmaceuticals Inc., by danger level
YearStop using nowUse cautionLower riskNot yet ratedTotal
201700123
2018133310
20190017623
20200112417
2021224513
2022103913
202300415
2024028414
202500246
2026 (to date)01304

Lupin Pharmaceuticals Inc. recalls before 2017

Recalls on record by year.

  • 20168
  • 20151
  • 20142
  • 20134

Most common reasons for Lupin Pharmaceuticals Inc. recalls

  • CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits6
  • CGMP Deviations: impurity N-nitrosoirbesartan detected in API5
  • Presence of Foreign substance: identified as a dead ant.3
  • Subpotent Drug3
  • Defective Container: Repetitive complaints received indicating pump not working.2

What to do if you have a recalled Lupin Pharmaceuticals 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 Lupin Pharmaceuticals Inc. recalls

60 shown

Lupin Pharmaceuticals Inc. recall questions

How many recalls has Lupin Pharmaceuticals Inc. had?

123 recalls from Lupin Pharmaceuticals Inc. are on record with U.S. safety agencies, from 2013–2026.

What is the most recent Lupin Pharmaceuticals Inc. recall?

Lupin Pharmaceuticals Inc. recalls Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, dated Aug 3, 2026. Every Lupin Pharmaceuticals Inc. recall is listed on this page, newest first.

Why are Lupin Pharmaceuticals Inc. products recalled?

The most common reasons on record: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits (6); CGMP Deviations: impurity N-nitrosoirbesartan detected in API (5); Presence of Foreign substance: identified as a dead ant. (3); Subpotent Drug (3).

What should I do if I have a recalled Lupin Pharmaceuticals 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 Lupin Pharmaceuticals 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.