Browse Drug Recalls

415 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 415 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 415 FDA drug recalls in N/A.

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DateProductReasonClassFirm
Jul 14, 2026 Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Ster... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polyso... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Ster... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polyso... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polyso... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jun 24, 2026 Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by:... Cross Contamination with Other Products: Customer complaints for appearance of discolored tablet... Class I JB Chemicals and Pharmaceuticals Ltd
Jun 24, 2026 Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, Fo... Lack of Sterility Assurance Class II Reliance Life Sciences Private Limited
Jun 24, 2026 Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For... Lack of Sterility Assurance Class II Reliance Life Sciences Private Limited
Jun 24, 2026 Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intraven... Lack of Sterility Assurance Class II Reliance Life Sciences Private Limited
Jun 24, 2026 Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For... Lack of Sterility Assurance Class II Reliance Life Sciences Private Limited
Jun 7, 2026 Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Ma... Failed Impurities/Degradation Specifications Class II ONESOURCE SPECIALTY PHARMA LIMITED
Jun 4, 2026 Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pha... Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet i... Class II Annora Pharma Private Limited
May 19, 2026 Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net ... cGMP deviations Class II Shimoga Chemicals
Apr 2, 2026 Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Via... Lack of Assurance of Sterility Class II Huons Co., Ltd.
Apr 2, 2026 Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials,... Lack of Assurance of Sterility Class II Huons Co., Ltd.
Apr 2, 2026 Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL)... Lack of Assurance of Sterility Class II Huons Co., Ltd.
Apr 2, 2026 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Pre... Lack of Assurance of Sterility Class II Huons Co., Ltd.
Mar 26, 2026 Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, ... Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than no... Class II Hetero Labs Limited (Unit V)
Mar 20, 2026 QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, C... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey L... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Me... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, ... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Va... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Men... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Straw... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, S... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Ho... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anest... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Su... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flav... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anest... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar F... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey L... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Feb 13, 2026 Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01... CGMP Deviations This recall has been initiated due to failing to complete process validation and ... Class II Harbin Jixianglong Biotech Co., Ltd.
Feb 13, 2026 Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-0... CGMP Deviations This recall has been initiated due to failing to complete process validation and ... Class II Harbin Jixianglong Biotech Co., Ltd.
Feb 3, 2026 Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactur... Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin... Class III Annora Pharma Private Limited
Dec 31, 2025 CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drop... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye D... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manu... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manuf... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 19, 2025 INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and ... Failed Disintegration Specifications: above the time expected. Class II Sato Pharmaceutical Co., Ltd
Oct 10, 2025 HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syr... Lack of Assurance of Sterility. Class II Samsung Bioepis Co., Ltd.
Aug 22, 2025 Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide... Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF res... Class II GRACE & FIRE PTY LTD
Aug 22, 2025 Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Min... Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF res... Class II GRACE & FIRE PTY LTD

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.