Browse Drug Recalls
14,136 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,136 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 14,136 FDA drug recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 24, 2024 | Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual... | Presence of Foreign Substance; Broken metal piece found embedded in tablet. | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Apr 23, 2024 | minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count... | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product ... | Class II | EPI Health, LLC |
| Apr 23, 2024 | EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-d... | Lack of Assurance of Sterility: Complaints of syringe breakage | Class II | Regeneron Pharmaceuticals Inc |
| Apr 23, 2024 | Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, N... | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product ... | Class II | EPI Health, LLC |
| Apr 23, 2024 | minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count... | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product ... | Class II | EPI Health, LLC |
| Apr 19, 2024 | Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: S... | Out of specification for assay | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 19, 2024 | FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips pe... | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... | Class II | Nomax Inc |
| Apr 19, 2024 | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx ... | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... | Class II | Nomax Inc |
| Apr 19, 2024 | FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein... | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... | Class II | Nomax Inc |
| Apr 19, 2024 | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx ... | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... | Class II | Nomax Inc |
| Apr 17, 2024 | ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octy... | Out of Specification for active ingredient | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octy... | Out of Specification for active ingredient | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched ... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Do... | Failed Dissolution Specifications | Class II | Glenmark Pharmaceuticals Inc., USA |
| Apr 17, 2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor ... | Out of Specification for active ingredient | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched ... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched ... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 12, 2024 | Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jar... | cGMP Deviations | Class II | Dercher Enterprises, Inc., DBA Gordon Laboratories |
| Apr 10, 2024 | Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solut... | Subpotent Drug | Class II | Imprimis NJOF, LLC |
| Mar 29, 2024 | Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents:... | CGMP Deviations | Class II | HONEYWELL INC |
| Mar 28, 2024 | Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx O... | Superpotent Drug: The 3-month stability result for assay was found to be above specification limit | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 27, 2024 | Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treat... | CGMP Deviations | Class II | NATCO Pharma Limited |
| Mar 26, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Do... | Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 26, 2024 | Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3... | Short fill: Complaints received of less fill volume in respule and few drops of liquid observed i... | Class II | Cipla USA, Inc. |
| Mar 25, 2024 | Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distr... | Failed Dissolution Specifications | Class II | Amneal Pharmaceuticals of New York, LLC |
| Mar 22, 2024 | fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, I... | Lack of Assurance of Sterility: leaking bags | Class II | IntegraDose Compounding Services LLC |
| Mar 22, 2024 | Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Me... | Lack of assurance of sterility: bags have the potential to leak.. | Class II | B. Braun Medical Inc |
| Mar 21, 2024 | VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9... | cGMP Diviations | Class II | Apothecus Pharmaceutical Corp. |
| Mar 21, 2024 | Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lu... | Subpotent Drug | Class II | Lupin Pharmaceuticals Inc. |
| Mar 12, 2024 | Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul,... | The filter included in the carton has an expiration date that has expired prior to the expiration... | Class II | Hikma Pharmaceuticals USA Inc. |
| Mar 12, 2024 | Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 RE... | CGMP Deviations | Class II | Eli Lilly & Company |
| Mar 7, 2024 | Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic ... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 6, 2024 | Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), ... | Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, spec... | Class II | B. Braun Medical Inc |
| Mar 5, 2024 | Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactu... | Lack of Assurance of Sterility: Out of specification for volume and compromised container closure. | Class II | Thea Pharma, Inc. |
| Mar 4, 2024 | Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufact... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 4, 2024 | Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufact... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 1, 2024 | S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging... | Failed Stability Specifications | Class II | Specialty Process Labs LLC |
| Mar 1, 2024 | S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or R... | Failed Stability Specifications | Class II | Specialty Process Labs LLC |
| Feb 29, 2024 | TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL ... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenou... | Lack of Assurance of Sterility: Firm did not perform process validation. | Class II | SSM Health Care St. Louis DBA SSM St. Clare Hea... |
| Feb 29, 2024 | TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manu... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufacture... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bot... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), ... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (... | Lack of Assurance of Sterility | Class II | Optikem International, 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.