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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.