Browse Drug Recalls

30 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 30 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 30 FDA drug recalls.

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DateProductReasonClassFirm
Jan 26, 2022 ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jul 27, 2021 Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 c... Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... Class II Perrigo Company PLC
Jul 27, 2021 GoodSense Aller.Ease, Fexofenadine hydrochloride 24 HR, 180 mg tablets, 30 co... Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... Class II Perrigo Company PLC
Jul 27, 2021 basic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, ... Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... Class II Perrigo Company PLC
Jul 27, 2021 basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine,... Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... Class II Perrigo Company PLC
Jul 27, 2021 Perrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 co... Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... Class II Perrigo Company PLC
Jul 27, 2021 GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 cou... Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... Class II Perrigo Company PLC
Mar 15, 2021 Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-12... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Dec 30, 2020 Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) S... Labeling: Missing instructions for use insert Class II Allergan, PLC.
Jul 6, 2020 Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distr... SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. Class III Allergan PLC
Jul 6, 2020 Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0... SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. Class III Allergan PLC
Mar 19, 2019 Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%... cGMP Deviations Class II Allergan Sales, LLC
Dec 20, 2018 OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic ap... GMP Deviations: A silicone particulate was noted in Ozurdex. Class II Allergan, PLC.
Nov 8, 2018 INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx ... Failed Stability Specification: out of specification for iron content. Class II ALLERGAN
May 24, 2018 Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians... Contraceptive Tablets Out of Sequence. Class I Allergan, PLC.
Feb 2, 2018 NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, ... Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classificati... Class III ALLERGAN
Dec 13, 2017 INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx ... Failed Stability Specifications: Product stability testing results did not meet specifications fo... Class II ALLERGAN
Dec 4, 2017 Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, ... Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did ... Class II ALLERGAN
Oct 19, 2017 Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, All... Failed Impurities/Degradation Specifications. Class III Allergan Sales, LLC
Oct 19, 2017 Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%... Failed Impurities/Degradation Specifications. Class III Allergan Sales, LLC
May 1, 2017 Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment... Failed Impurities/Degradation Specifications: stability testing results did not meet the specific... Class II Allergan Sales, LLC
Mar 16, 2017 Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Alle... Failed Impurities/Degradation Specifications Class III Allergan Sales, LLC
Jun 30, 2016 TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional ... Failed Content Uniformity Specifications Class II Allergan Sales, LLC
Jun 30, 2016 TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for O... Failed Content Uniformity Specifications Class II Allergan Sales, LLC
May 10, 2016 Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvin... Failed Content Uniformity Specifications. Class II Allergan Sales, LLC
May 10, 2016 Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03... Failed Content Uniformity Specifications. Class II Allergan Sales, LLC
Aug 24, 2015 Refresh P.M. (Mineral Oil 42.5% and White Petrolatum 57.3%) Lubricant Eye Oin... Presence of Particulate Matter: Due to customer complaints of small black particles, identified a... Class II Allergan Sales, LLC
Aug 24, 2015 BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment... Presence of Particulate Matter: Due to customer complaints of small black particles, identified a... Class II Allergan Sales, LLC
Aug 24, 2015 FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan... Presence of Particulate Matter: Due to customer complaints of small black particles, identified a... Class II Allergan Sales, LLC
Aug 24, 2015 Refresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant E... Presence of Particulate Matter: Due to customer complaints of small black particles, identified a... Class II Allergan Sales, LLC

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.