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Browse Drug Recalls

35 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 35 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 35 FDA drug recalls.

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DateProductReasonClassFirm
Apr 26, 2023 Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TEC... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, F... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured ... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, Fo... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Aug 1, 2022 PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TE... Defective Container: Product has incomplete induction seals. Class II Akorn, Inc
Jun 13, 2022 Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amb... Defective container: defect prevents product from dispensing as intended. Class II Akorn, Inc.
Jun 10, 2022 Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl... Defective Delivery System: Potential defect that could prevent the product from dispensing as int... Class II Akorn, Inc.
Apr 15, 2022 Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per b... Failed viscosity specification - product was below specificcation Class III Akorn, Inc.
Mar 15, 2022 Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufact... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Dec 3, 2021 Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bo... Labeling: Missing Label Class III Akorn, Inc.
Dec 3, 2021 Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx o... Labeling: Missing Label Class III Akorn, Inc.
Dec 28, 2020 Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI... Defective container: Customer complaints for oral solution leaking from bottles. Class II Akorn, Inc.
Jun 5, 2020 Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx onl... Discoloration: Out of Specification (OOS) result for APHA Color Test. Class III Akorn, Inc.
Dec 16, 2019 Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx o... Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of th... Class II Akorn Inc
Mar 28, 2019 Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx on... Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was ob... Class III Akorn, Inc.
Aug 1, 2018 Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by... Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impuri... Class II Akorn, Inc.
Mar 29, 2018 Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-72... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, Inc.
Mar 29, 2018 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Pa... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, Inc.
Mar 29, 2018 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Pa... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, Inc.
Dec 15, 2017 Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bo... CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufact... Class III Akorn Inc
Feb 7, 2017 Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx... Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at... Class III Actavis Inc
Jun 1, 2016 CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. ... Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity. Class II Aidarex Pharmaceuticals LLC
Jun 1, 2016 Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, ... Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity. Class III Aidarex Pharmaceuticals LLC
Mar 23, 2016 Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PE... Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) ... Class II Akorn, Inc.
Apr 7, 2015 Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) b... Failed Impurities/Degradation Specifications Class II Akorn, Inc.
Apr 7, 2015 Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) b... Failed Impurities/Degradation Specifications Class II Akorn, Inc.
Feb 27, 2015 Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bo... Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride. Class II Akorn, Inc.
Apr 1, 2014 HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (4... Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown... Class II Hi-Tech Pharmacal Co., Inc.
Oct 28, 2013 Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx onl... Failed Stability Specification; product viscosity and or pH are below specification. Class III Hi-Tech Pharmacal Co., Inc.
Sep 4, 2013 GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-... Subpotent; phenylephrine HCl Class III Hi-Tech Pharmacal Co., Inc.
Jul 25, 2013 Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL... Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes lab... Class III Hi-Tech Pharmacal Co., Inc.
Apr 30, 2013 HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL)... Subpotent; 24 month stability test station Class III Hi-Tech Pharmacal Co., Inc.
Apr 8, 2013 BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 m... Subpotent; Cetylpyridinum Chloride Class III Hi-Tech Pharmacal Co., Inc.
Mar 11, 2013 Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co.,... Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the... Class III Hi-Tech Pharmacal Co., 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.