Browse Drug Recalls
119 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 119 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 119 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 13, 2025 | Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syr... | Failed impurities/degradation specifications: out of specification results for Ganirelix acetate ... | Class II | Lupin Pharmaceuticals Inc. |
| Nov 5, 2025 | Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Ma... | Defective container - seal not adhering to bottles | Class II | Lupin Pharmaceuticals Inc. |
| Jul 2, 2025 | Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle,... | Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 i... | Class II | Lupin Pharmaceuticals Inc. |
| Jun 27, 2025 | clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelica... | Failed Impurities/Degradation Specifications: an out of specification result observed in degradat... | Class II | Lupin Pharmaceuticals Inc. |
| Jun 20, 2025 | Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles... | Product Mix Up: This product is being recalled because of a complaint received that a sealed bott... | Class II | Lupin Pharmaceuticals Inc. |
| Apr 10, 2025 | clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Ma... | Failed Impurities/Degradation Specifications: an out of specification result observed in degradat... | Class II | Lupin Pharmaceuticals Inc. |
| Dec 20, 2024 | Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only,... | Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug s... | Class II | Lupin Pharmaceuticals Inc. |
| Oct 23, 2024 | Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC ... | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor | Class II | Lupin Pharmaceuticals Inc. |
| Oct 23, 2024 | Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count ND... | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor | Class II | Lupin Pharmaceuticals Inc. |
| Oct 23, 2024 | Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC... | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor | Class II | Lupin Pharmaceuticals Inc. |
| Aug 21, 2024 | Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufac... | Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month lon... | Class II | Lupin Pharmaceuticals Inc. |
| May 30, 2024 | Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for or... | Failed Content Uniformity Specifications | Class II | Lupin Pharmaceuticals Inc. |
| May 8, 2024 | Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx... | Defective container: lack of seal integrity. | Class II | Lupin Pharmaceuticals Inc. |
| Apr 24, 2024 | Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 m... | Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. | Class II | Lupin Pharmaceuticals Inc. |
| Apr 24, 2024 | Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 m... | Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. | Class II | Lupin Pharmaceuticals Inc. |
| Mar 21, 2024 | Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lu... | Subpotent Drug | Class II | Lupin Pharmaceuticals Inc. |
| Feb 5, 2024 | Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when rec... | Labeling: Incorrect or Missing Package Insert | Class II | Lupin Pharmaceuticals Inc. |
| Jan 5, 2024 | Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lup... | Subpotent Drug and Failed Impurities/Degradation Specifications | Class II | Lupin Pharmaceuticals Inc. |
| Jan 5, 2024 | Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lu... | Subpotent Drug and Failed Impurities/Degradation Specifications | Class II | Lupin Pharmaceuticals Inc. |
| Jan 3, 2024 | Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured f... | Failed Impurities/Degradation Specifications | Class II | Lupin Pharmaceuticals Inc. |
| Dec 20, 2023 | Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 coun... | CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit. | Class II | Lupin Pharmaceuticals Inc. |
| Nov 22, 2023 | Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for... | Failed Dissolution Specifications | Class II | Lupin Pharmaceuticals Inc. |
| Jun 27, 2023 | Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufact... | Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term st... | Class III | Lupin Pharmaceuticals Inc. |
| Jun 23, 2023 | Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 m... | Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specific... | Class I | Lupin Pharmaceuticals Inc. |
| Jan 20, 2023 | Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for:... | Subpotent Drug: Low assay result observed during long-term stability testing. | Class III | Lupin Pharmaceuticals Inc. |
| Dec 12, 2022 | Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lu... | Failed Impurities/Degradation Specifications: Failure observed in related substance testing durin... | Class II | Lupin Pharmaceuticals Inc. |
| Dec 7, 2022 | Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Phar... | CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. | Class II | Lupin Pharmaceuticals Inc. |
| Dec 7, 2022 | Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Phar... | CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. | Class II | Lupin Pharmaceuticals Inc. |
| Sep 13, 2022 | Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for:... | Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. | Class II | Lupin Pharmaceuticals Inc. |
| Jul 28, 2022 | Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured ... | CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity. | Class II | Lupin Pharmaceuticals Inc. |
| Jun 10, 2022 | Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufac... | Failed Dissolution Specifications: Out of specification test results observed in dissolution test... | Class II | Lupin Pharmaceuticals Inc. |
| Apr 27, 2022 | GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solut... | Failed Stability Specification | Class II | Lupin Pharmaceuticals Inc. |
| Mar 31, 2022 | Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Lupin Pharmaceuticals Inc. |
| Mar 31, 2022 | Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Lupin Pharmaceuticals Inc. |
| Mar 31, 2022 | Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-c... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Lupin Pharmaceuticals Inc. |
| Mar 31, 2022 | Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Lupin Pharmaceuticals Inc. |
| Mar 31, 2022 | Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Lupin Pharmaceuticals Inc. |
| Mar 31, 2022 | Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Lupin Pharmaceuticals Inc. |
| Dec 29, 2021 | Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, ... | Out-of-specification impurity test result observed at 18-month long term stability time point. | Class III | Lupin Pharmaceuticals Inc. |
| Dec 22, 2021 | Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured ... | Failed Stability Specifications: Out-of-specification results observed in a water loss test that ... | Class III | Lupin Pharmaceuticals Inc. |
| Nov 19, 2021 | Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/... | Subpotent Drug | Class III | Lupin Pharmaceuticals Inc. |
| Oct 20, 2021 | Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured ... | Failed Stability Specifications: Out-of-specification results observed in a water loss test that ... | Class III | Lupin Pharmaceuticals Inc. |
| Oct 12, 2021 | Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC... | CGMP Deviations: impurity N-nitrosoirbesartan detected in API | Class II | Lupin Pharmaceuticals Inc. |
| Oct 12, 2021 | Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count... | CGMP Deviations: impurity N-nitrosoirbesartan detected in API | Class II | Lupin Pharmaceuticals Inc. |
| Oct 12, 2021 | Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 coun... | CGMP Deviations: impurity N-nitrosoirbesartan detected in API | Class II | Lupin Pharmaceuticals Inc. |
| Oct 12, 2021 | Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 coun... | CGMP Deviations: impurity N-nitrosoirbesartan detected in API | Class II | Lupin Pharmaceuticals Inc. |
| Oct 12, 2021 | Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC... | CGMP Deviations: impurity N-nitrosoirbesartan detected in API | Class II | Lupin Pharmaceuticals Inc. |
| Oct 8, 2021 | Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured fo... | Out of specification result observed in a dissolution test at the 9-month long term stability tim... | Class II | Lupin Pharmaceuticals Inc. |
| Apr 29, 2021 | Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manu... | Subpotent Drug | Class II | Lupin Pharmaceuticals Inc. |
| Mar 26, 2021 | Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixe... | Superpotent Drug | Class II | Lupin Pharmaceuticals Inc. |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.