Allergan Sales, LLC
Allergan Sales, LLC has 14 FDA recalls, 39 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- Z-1694-2024 · Class II · Mar 14, 2024
- Latest inspection
- Sep 19, 2025 · NAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 14 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 39 | Nov 13, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 1 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 1 | 0 | 0 |
| 2019 | 5 | 0 | 0 | 1 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 4 | 0 |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1694-2024 | Class II | Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only, | Mar 14, 2024 |
| D-1056-2019 | Class II | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only… | Mar 19, 2019 |
| D-0078-2018 | Class III | Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA… | Oct 19, 2017 |
| D-0077-2018 | Class III | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in… | Oct 19, 2017 |
| D-0929-2017 | Class II | Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%… | May 1, 2017 |
| D-0667-2017 | Class III | Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612… | Mar 16, 2017 |
| D-0099-2017 | Class II | TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged… | Jun 30, 2016 |
| D-0100-2017 | Class II | TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers… | Jun 30, 2016 |
| D-1064-2016 | Class II | Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC… | May 10, 2016 |
| D-1065-2016 | Class II | Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvine, CA 92612. UPC… | May 10, 2016 |
| D-1817-2015 | Class II | Refresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant Eye Ointment, packaged… | Aug 24, 2015 |
| D-1819-2015 | Class II | FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA… | Aug 24, 2015 |
| D-1820-2015 | Class II | BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 %/0.2 %, 3.5… | Aug 24, 2015 |
| D-1818-2015 | Class II | Refresh P.M. (Mineral Oil 42.5% and White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt. 0.12 oz… | Aug 24, 2015 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 19, 2025 | Irvine, CA | Devices | No Action Indicated (NAI) | 2011068 |
| Sep 3, 2024 | Campbell, CA | Drugs | No Action Indicated (NAI) | 3000720089 |
| Jul 28, 2023 | Irvine, CA | Drugs | No Action Indicated (NAI) | 2011068 |
| Mar 24, 2022 | Waco, TX | Drugs | No Action Indicated (NAI) | 1643525 |
| Jun 24, 2021 | Cincinnati, OH | Drugs | Voluntary Action Indicated (VAI) | 1523957 |
| Jul 29, 2019 | Cincinnati, OH | Drugs | Voluntary Action Indicated (VAI) | 1523957 |
| Jun 6, 2019 | Madison, NJ | Drugs | No Action Indicated (NAI) | 3012867780 |
| Apr 11, 2019 | Madison, NJ | Drugs | Voluntary Action Indicated (VAI) | 3012867780 |
| Feb 27, 2019 | Waco, TX | Drugs | Voluntary Action Indicated (VAI) | 1643525 |
| Jan 22, 2019 | Irvine, CA | Devices | No Action Indicated (NAI) | 2011068 |
| May 2, 2018 | Madison, NJ | Drugs | Voluntary Action Indicated (VAI) | 3012867780 |
| Feb 1, 2017 | Campbell, CA | Drugs | No Action Indicated (NAI) | 3000720089 |
| Oct 28, 2016 | Waco, TX | Drugs | Voluntary Action Indicated (VAI) | 1643525 |
| Oct 19, 2016 | Irvine, CA | Devices | No Action Indicated (NAI) | 2011068 |
| Sep 1, 2016 | Madison, NJ | Drugs | Voluntary Action Indicated (VAI) | 3012867780 |
| May 20, 2016 | Cincinnati, OH | Drugs | No Action Indicated (NAI) | 1523957 |
| Jan 15, 2016 | Irvine, CA | Drugs | Voluntary Action Indicated (VAI) | 2011068 |
| Dec 7, 2015 | Irvine, CA | Devices | No Action Indicated (NAI) | 2011068 |
| Oct 8, 2015 | Waco, TX | Drugs | Voluntary Action Indicated (VAI) | 1643525 |
| Sep 22, 2015 | Cincinnati, OH | Drugs | No Action Indicated (NAI) | 1523957 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Allergan Sales, LLC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 2011068 | Irvine, CA | 13 | Sep 19, 2025 |
| FEI 3000720089 | Campbell, CA | 5 | Sep 3, 2024 |
| FEI 1643525 | Waco, TX | 9 | Mar 24, 2022 |
| FEI 1523957 | Cincinnati, OH | 8 | Jun 24, 2021 |
| FEI 3012867780 | Madison, NJ | 4 | Jun 6, 2019 |
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