Haleon US HOLDINGS LLC — FDA Facility Profile
Haleon US HOLDINGS LLC is an FDA-registered facility (FEI 3012293198) located in Warren, NJ, US. RegDataLab tracks 2 FDA inspections at this facility.
Reviewing Haleon US HOLDINGS LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Haleon US HOLDINGS LLC yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
What FDA found at this site
- Latest inspection
- Nov 22, 2024: No Action Indicated (NAI)
- Inspections on record
- 2 (2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 14, latest Jun 4, 2026
- Import refusals
- 8
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Nov 22, 2024 | No Action Indicated (NAI) | No citations listed |
| Dec 16, 2022 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jun 4, 2026 | Class I | D-0595-2026 | Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674… Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. |
| May 11, 2026 | Class II | D-0542-2026 | Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ… Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling. |
| Dec 26, 2025 | Class III | D-0297-2026 | parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ… Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles. |
| Dec 26, 2023 | Class I | D-0316-2024 | Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20… and 1 more product Microbial Contamination of Non-Sterile Products |
| Dec 6, 2022 | Class I | D-0181-2023 | Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 0154 60… and 2 more products Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back |
| Jun 16, 2020 | Class II | D-1361-2020 | Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough… and 1 more product Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. |
| May 28, 2020 | Class II | D-1322-2020 | Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK… and 3 more products Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. |
| Apr 28, 2020 | Class II | F-0950-2020 | Benefiber Healthy Shape Prebiotic Fiber Supplement, 500G
UPC 886790018872 and 1 more product Fiber prebiotic product potentially contaminated with small plastic pieces |
| Apr 20, 2020 | Class III | D-1266-2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g)… and 2 more products Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card |
| Mar 16, 2020 | Class II | D-1065-2020 | Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets.
Advil Allergy… and 4 more products Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. |
Facility details
- Company
- Haleon US Holdings LLC
- Location
- Warren, NJ (US)
- Source
- device