Allergan Sales, LLC
Complete recall history across all FDA and CPSC categories — 14 total recalls
Recall Summary
Allergan Sales, LLC appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (13)
FDA drug safety enforcement actions by Allergan Sales, LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 19, 2019 | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%... | cGMP Deviations | Class II |
| Oct 19, 2017 | Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, All... | Failed Impurities/Degradation Specifications. | Class III |
| Oct 19, 2017 | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%... | Failed Impurities/Degradation Specifications. | Class III |
| May 1, 2017 | Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment... | Failed Impurities/Degradation Specifications: stability testing results did n... | Class II |
| Mar 16, 2017 | Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Alle... | Failed Impurities/Degradation Specifications | Class III |
| Jun 30, 2016 | TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional ... | Failed Content Uniformity Specifications | Class II |
| Jun 30, 2016 | TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for O... | Failed Content Uniformity Specifications | Class II |
| May 10, 2016 | Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvin... | Failed Content Uniformity Specifications. | Class II |
| May 10, 2016 | Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03... | Failed Content Uniformity Specifications. | Class II |
| 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 par... | Class II |
| Aug 24, 2015 | BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment... | Presence of Particulate Matter: Due to customer complaints of small black par... | Class II |
| 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 par... | Class II |
| 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 par... | Class II |
Device Recalls (1)
FDA medical device enforcement actions by Allergan Sales, LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 14, 2024 | Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only, | Their is a potential that breast implants lack the lubricious coating that a... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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