Lupin Pharmaceuticals recalls
38 official recalls and safety alerts involving Lupin Pharmaceuticals since 2021-10, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Lupin Pharmaceuticals or the relevant agency.
- 2026-09-02
US- 2026-07-08
- US
Lupin Pharmaceuticals Inc. recalls Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only,…
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
- US
- 2026-05-27
- US
Lupin Pharmaceuticals Inc. recalls Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured…
Presence of particulate matter: a white thread-like structure in the cartridge
- 2025-12-17
- US
Lupin Pharmaceuticals Inc. recalls Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL…
Defective container - seal not adhering to bottles
- US
Lupin Pharmaceuticals Inc. recalls Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for:…
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
- 2025-08-06
- US
Lupin Pharmaceuticals Inc. recalls Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc.,…
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
- 2025-07-30
- US
Lupin Pharmaceuticals Inc. recalls clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC#…
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
- 2025-07-23
- US
Lupin Pharmaceuticals Inc. recalls Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: 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…
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed nationwide within the United States.Official notice → - 2025-04-30
- US
Lupin Pharmaceuticals Inc. recalls clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore,…
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.
- 2025-01-08
- US
Lupin Pharmaceuticals Inc. recalls Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore,…
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
- 2024-11-27
- US
Lupin Pharmaceuticals Inc. recalls Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02)…
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed to 30 wholesalers/distributors who may have further…Official notice → - 2024-09-04
- US
Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore,…
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
- 2024-06-26
- US
Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin…
Failed Content Uniformity Specifications
- 2024-06-05
- US
Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc.,…
Defective container: lack of seal integrity.
- 2024-05-22
- US
Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin…
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
- 2024-04-17
- US
- 2024-02-28
- US
Lupin Pharmaceuticals Inc. recalls Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release…
Labeling: Incorrect or Missing Package Insert
- 2024-02-07
- US
Lupin Pharmaceuticals Inc. recalls Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United…
Subpotent Drug and Failed Impurities/Degradation Specifications
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed to 32 Wholesale/distributor accounts who further…Official notice → - US
Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland…
Failed Impurities/Degradation Specifications
- 2024-01-17
- US
Lupin Pharmaceuticals Inc. recalls Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for:…
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
- 2023-12-20
- US
Lupin Pharmaceuticals Inc. recalls Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202…
Failed Dissolution Specifications
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed to 3 wholesale/distributor accounts.Official notice → - 2023-08-09
- US
Lupin Pharmaceuticals Inc. recalls Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451…
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
- 2023-07-19
- US
Lupin Pharmaceuticals Inc. recalls Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland…
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed directly to three distributors in TN and NJ. Product…Official notice → - 2023-02-01
- US
Lupin Pharmaceuticals Inc. recalls Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202,…
Subpotent Drug: Low assay result observed during long-term stability testing.
- 2023-01-18
- US
Lupin Pharmaceuticals Inc. recalls Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202,…
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
- 2022-12-28
- US
Lupin Pharmaceuticals Inc. recalls Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin…
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed by major distribution chains nationwide.Official notice → - 2022-09-21
- US
Lupin Pharmaceuticals Inc. recalls Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202,…
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed to major distributors/wholesalers nationwide.Official notice → - 2022-08-24
- US
Lupin Pharmaceuticals Inc. recalls Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202…
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
- 2022-06-22
- US
Lupin Pharmaceuticals Inc. recalls Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD…
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed to 10 wholesalers/distributors and one mail order…Official notice → - 2022-05-25
- US
Lupin Pharmaceuticals Inc. recalls GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Failed Stability Specification
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed nationwide, including Puerto Rico.Official notice → - 2022-05-11
- US
Lupin Pharmaceuticals Inc. recalls Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only,…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-01-12
- US
Lupin Pharmaceuticals Inc. recalls Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore,…
Out-of-specification impurity test result observed at 18-month long term stability time point.
- US
Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC…
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
- 2021-12-08
- US
- 2021-11-10
- US
Lupin Pharmaceuticals Inc. recalls Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09)…
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed to major distributors who may have further distributed…Official notice → - 2021-11-03
- US
Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC…
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
- 2021-10-27
- US
Lupin Pharmaceuticals Inc. recalls Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…
Out of specification result observed in a dissolution test at the 9-month long term stability time point.