Lupin Pharmaceuticals recalls
FDA enforcement reports naming Lupin Pharmaceuticals Inc. as the recalling firm.
- Recall reports
- 123
- Class I (serious)
- 5
- Most recent report
- Sep 2, 2026
- Sep 2, 2026Clobetasol Propionate Cream USP, 0Drug · Lupin Pharmaceuticals Inc.Failed content uniformity specifications.Class II
- Jul 8, 2026prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 707…Drug · Lupin Pharmaceuticals Inc.Presence of Foreign SubstanceClass II
- Jul 8, 2026Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, D…Drug · Lupin Pharmaceuticals Inc.CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.Class II
- May 27, 2026Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceu…Drug · Lupin Pharmaceuticals Inc.Presence of particulate matter: a white thread-like structure in the cartridgeClass II
- Dec 17, 2025Ganirelix Acetate Injection, 250 mcg/0Drug · Lupin Pharmaceuticals Inc.Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.Class II
- Dec 17, 2025Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured…Drug · Lupin Pharmaceuticals Inc.Defective container - seal not adhering to bottlesClass II
- Aug 6, 2025Amlodipine and Benazepril HCl Capsules USP 2Drug · Lupin Pharmaceuticals Inc.Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027Class II
- Jul 30, 2025clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boul…Drug · Lupin Pharmaceuticals Inc.Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.Class II
- Jul 23, 2025Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12Drug · Lupin Pharmaceuticals Inc.Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir…Class II
- Apr 30, 2025clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured…Drug · Lupin Pharmaceuticals Inc.Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.Class II
- Levothyroxine Sodium Tablets, Lupin, 75 mcg (0
- Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591…
- Ramipril Capsules USP 2
- Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-…
- Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for:…
- Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspens…
- Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Man…
- Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle,…
- Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle,…
- Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharma…
- Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted
- Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmac…
- Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin…
- Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharma…
- Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 681…
- Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Ph…
- Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0
- Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for:…
- Clobetasol propionate Cream USP, 0
- Rifampin Capsules USP, 300 mg, 30-count bottle
- Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceutical…
- Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceutical…
- Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pha…
- Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin…
- Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for…
- GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP w…
- Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000…
- Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12
- Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 10…
- Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000…
- Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12
- Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottl…
- Gatifloxacin Ophthalmic Solution, 0
- Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactur…
- Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0
- Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 681…
- Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 6818…
- Irbesartan and Hydrochlorothiazide Tablets USP, 300/12
- Irbesartan and Hydrochlorothiazide Tablets USP, 150/12
- Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 681…
- Gatifloxacin Ophthalmic Solution, 0
- Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Ph…
- Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured b…
- Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles…
- Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitu…
- Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate…
- Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagp…
- Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manuf…
- Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only…
- Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only,…
- Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only…
- Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only…
- Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only,…
- Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Phar…
- Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceu…
- Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Phar…
- Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharm…
- Levonorgestrel and Ethinyl Estradiol Tablets USP, 0
- Bekyree (desogestrel and ethinyl estradiol tablets USP, 0
- Desoximetasone Topical Spray, 0
- Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Ma…
- Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0
- Blisovi Fe 1
- Bimatoprost Ophthalmic Solution, 0
- Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottle…
- Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured fo…
- Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for:…
- Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-72…
- Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12
- Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0
- Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12
- Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0
- Gatifloxacin Ophthalmic Solution 0
- Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle,…
- Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured…
- Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0
- Testosterone Topical Solution, 30mg/1
- Moxifloxacin Ophthalmic Solution USP, 0
- Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-cou…
- Moxifloxacin Ophthalmic Solution USP, 0
- Bimatoprost Ophthalmic Solution 0
- Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharma…
- Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactur…
- Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-61…
- Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)…
- Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)…
- Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01)…
- Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-0…
- Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-62…
- Testosterone Topical Solution, 30mg/1
- Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Phar…
- Moxifloxacin Ophthalmic Solution USP, 0
- My Way (Levonorgestrel) Tablets TWO PACK, 1
- My Way (levonorgestrel) Tablets TWO PACK, 1
- Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68…
- Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured…
- Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for…
- Paroxetine Extended-Release Tablets USP, 12
- Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc
- Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and…
- Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pha…
- Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12
- Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials pe…
- Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No
- Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-c…
- Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials pe…
- Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-c…
- Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx…
- Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx onl…
- Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharma…
- Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmac…
- Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured…
- Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstitut…
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