Browse Drug Recalls
3,394 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,394 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 3,394 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 30, 2023 | Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Ey... | CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because th... | Class II | Global Pharma Healthcare Private Limited |
| Jan 30, 2023 | Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG i... | CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because th... | Class II | Global Pharma Healthcare Private Limited |
| Jan 17, 2023 | Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged... | CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to ... | Class II | Fisher Scientific Co., LLC |
| Jan 17, 2023 | Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 ... | CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to ... | Class II | Fisher Scientific Co., LLC |
| Jan 17, 2023 | Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 M... | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... | Class II | Urban Electric Power |
| Jan 17, 2023 | Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles. | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... | Class II | Urban Electric Power |
| Jan 12, 2023 | Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose... | CGMP Deviations: potential for trace amounts of product carryover. | Class II | Nephron Sc Inc |
| Jan 12, 2023 | 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Onl... | CGMP Deviations: potential for trace amounts of product carryover. | Class II | Nephron Sc Inc |
| Jan 10, 2023 | Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle... | CGMP Deviations: initiated due to violations of CGMP manufacturing practices | Class II | Consolidated Chemical, Inc |
| Jan 10, 2023 | Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Sai... | CGMP Deviations: initiated due to violations of CGMP manufacturing practices | Class II | Consolidated Chemical, Inc |
| Dec 22, 2022 | Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular In... | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Class II | Pine Pharmaceuticals, LLC |
| Dec 15, 2022 | Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8... | cGMP Deviations | Class II | Frenda Corporation |
| Dec 15, 2022 | Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Fr... | cGMP Deviations | Class II | Frenda Corporation |
| Dec 15, 2022 | Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL... | cGMP Deviations | Class II | Frenda Corporation |
| Dec 15, 2022 | Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 m... | cGMP Deviations | Class II | Frenda Corporation |
| Dec 15, 2022 | Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 918... | cGMP Deviations | Class II | Frenda Corporation |
| Dec 15, 2022 | Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (1... | cGMP Deviations | Class II | Frenda Corporation |
| Dec 15, 2022 | Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gall... | cGMP Deviations | Class II | Frenda Corporation |
| Dec 12, 2022 | Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged... | cGMP Deviations | Class II | Atlantic Management Resources Ltd. |
| Dec 12, 2022 | Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g)... | cGMP Deviations | Class II | Atlantic Management Resources Ltd. |
| Dec 12, 2022 | ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 ... | cGMP Deviations | Class II | Atlantic Management Resources Ltd. |
| Dec 12, 2022 | Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g... | cGMP Deviations | Class II | Atlantic Management Resources Ltd. |
| Dec 9, 2022 | Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution,... | CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess o... | Class II | NCH Life Sciences LLC |
| 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. |
| 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. |
| Nov 10, 2022 | PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 5... | CGMP Deviations: Potential for cross contamination due to product carry over. | Class II | Nephron Sterile Compounding Center LLC |
| Nov 10, 2022 | PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only... | CGMP Deviations: Potential for cross contamination due to product carry over. | Class II | Nephron Sterile Compounding Center LLC |
| Nov 9, 2022 | Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Cont... | CGMP deviations | Class II | DISCOVERY PHARMA LLC |
| Nov 5, 2022 | Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, pack... | CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured u... | Class II | Adam's Polishes LLC |
| Nov 2, 2022 | Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distribut... | cGMP deviation: discontinue of stability support for product. | Class II | Direct Rx |
| Oct 13, 2022 | AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment ... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 m... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manu... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper b... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx O... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) pe... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufa... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL droppe... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-7... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactur... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufact... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, ... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dro... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, ... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tub... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bo... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only... | CGMP Deviations: | Class II | Akorn, 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.