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Browse Drug Recalls

295 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 295 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 295 FDA drug recalls in AR.

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DateProductReasonClassFirm
Apr 15, 2025 HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette,... Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was ... Class III OurPharma LLC
Feb 20, 2025 Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Ca... Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and... Class I One Source Nutrition, Inc,
Feb 18, 2025 Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, ... Lack of Assurance of Sterility: due to a quality control process deviation. During an internal qu... Class II Turbare Manufacturing
Jan 13, 2023 FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free ... Short Fill: Underfilled units. Class III OurPharma LLC
Nov 29, 2022 FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Fre... Underfilled units. Class II OurPharma LLC
May 24, 2022 Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles,... Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofen... Class I Walmart Inc
May 24, 2022 Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottl... Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labe... Class II Walmart Inc
May 24, 2022 Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets, ORIGINAL, 100-count bo... Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labe... Class II Walmart Inc
Mar 10, 2022 ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solu... CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specificatio... Class II Rock Town Distillery, Inc.
Feb 9, 2022 Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Cap... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ing... Class I Walmart Stores
Dec 16, 2020 Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx ... Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in... Class III US Compounding Inc
Dec 14, 2020 Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dos... Subpotent drug. Class II SCA Pharmaceuticals, Inc.
Nov 25, 2020 Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospit... Labelling: Missing label. Class III US Compounding Inc
Aug 17, 2020 Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural... Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be cont... Class I Maison Terre, LLC
Jan 29, 2019 Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compoun... Lack of assurance of sterility. Class II US Compounding Inc
Jan 24, 2019 LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), ... Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date an... Class II US Compounding Inc
Aug 27, 2018 Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Sing... Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the... Class I SCA Pharmaceuticals, Inc.
Jun 29, 2018 Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic ... Subpotent Drug: Stability data does not support the current expiration dating of 55 days after co... Class II SCA Pharmaceuticals
Dec 7, 2017 Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syring... Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and bey... Class II SCA Pharmaceuticals
Oct 19, 2017 ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride ... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag conta... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUC... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL ... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL sin... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose ... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmace... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (20... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Jul 14, 2017 Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg ... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantre... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 m... Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have t... Class II SCA Pharmaceuticals
Jul 14, 2017 EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceut... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only,... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmac... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmace... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA P... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx onl... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg p... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Adenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syr... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA ... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose S... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA ... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg ... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Succinylcholine Chloride Injection Solution 5 mL, 100 mg/5 mL (20 mg/mL) Sing... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Pre... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 Ephedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA P... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals

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.