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Browse Drug Recalls

13 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 13 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 13 FDA drug recalls.

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DateProductReasonClassFirm
Mar 19, 2019 Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%... cGMP Deviations Class II Allergan Sales, LLC
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.