Browse Drug Recalls

180 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 180 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 180 FDA drug recalls in MD.

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DateProductReasonClassFirm
Oct 8, 2025 Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syring... Lack of Assurance of Sterility: Class II ASTRAZENECA PHARMACEUTICALS
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.
Feb 3, 2023 Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx on... Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus. Class II Leadiant Biosciences, 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 27, 2022 Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cad... Subpotent Drug: Out of specification for assay at the 18-month stability timepoint. Class III Jubilant Cadista 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.
Jul 18, 2022 Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: ... Failed dissolution specifications. Class II Jubilant Cadista Pharmaceuticals, Inc.
Jul 18, 2022 Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: J... Failed Dissolution Specifications Class II Jubilant Cadista 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.
Apr 1, 2022 Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured ... Subpotent Class III Jubilant Cadista 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.
Mar 8, 2022 Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottle... Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydroc... Class I Jubilant Cadista 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.
Dec 3, 2021 Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape... Lack of Processing Controls Class II Valgene Incorporated dba Cape Drugs
Dec 3, 2021 B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Ro... Lack of Processing Controls Class II Valgene Incorporated dba Cape Drugs
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.

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.