Witch hazel product recalled for improper storage temperature conditions
Witch hazel product distributed to Family Dollar Stores from April through June 2022 was stored at improper temperatures. The FDA issued a Class II recall due to manufacturing and quality control (CGMP) deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II drug recall related to CGMP deviations involving product stored outside appropriate temperature conditions. No illnesses or injuries have been reported in the source text. The storage temperature deviation poses a potential risk to product safety and efficacy, but the precautionary nature and absence of reported harm limit the severity to High.
Plain-English summary
T.N. Dickinson Witch Hazel 16 fl oz (SKU 900911) has been recalled by the FDA. The product was distributed to select Family Dollar Stores locations nationwide from April 30, 2022 through June 10, 2022.
The FDA issued this Class II recall due to Good Manufacturing Practice (CGMP) deviations. The affected product was held outside appropriate storage temperature conditions.
Consumers should not use this product. Affected units should be discarded or returned to the point of purchase. Consumers with questions or concerns should contact the FDA or consult a healthcare provider.
The recalled product
- Product
- TN DICKINSON WITCH HAZEL 16 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Manufacturer
- Family Dollar Stores, Llc.
- Category
- Drug — Topical
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- SKU: 900911
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 recalled by Family Dollar Stores, Llc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 100 products in this recall →Related recalls
Same manufacturer · Family Dollar Stores, Llc.
See all →- ModerateFamily Dollar marijuana test strips recalled over improper storage
FDA (Devices) · 2023-11-15
- HighFamily Dollar Pregnancy Test Recalled Due to Improper Storage Conditions
FDA (Devices) · 2023-11-15
- ModerateFirst Response 2 CT Recalled for Improper Temperature Storage
FDA (Devices) · 2023-11-15
- ModerateFixodent Denture Cream Recalled Due to Improper Storage Conditions
FDA (Devices) · 2023-11-15
- ModerateOral B Mouth Sore Rinse Recall Due to Improper Storage Conditions
FDA (Devices) · 2023-11-15
Same hazard · temperature deviation
See all →- ModerateCitalopram Tablets Recalled for Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- HighDonepezil Hydrochloride Tablets Recalled Due to Storage Temperature Deviations
FDA (Drugs) · 2024-01-03
- ModerateLeader Nasal Decongestant PE recalled due to improper storage conditions
FDA (Drugs) · 2024-01-03
- ModerateAmoxicillin oral suspension recalled for temperature storage deviation
FDA (Drugs) · 2024-01-03
- HighLow-dose aspirin recall due to improper storage temperature conditions
FDA (Drugs) · 2024-01-03
Similar recalls
- HighGS Saline Solution recalled due to improper temperature storage
FDA (Devices) · 2022-08-24
- HighSimply Saline Nasal Mist Recalled for Improper Storage Conditions
FDA (Devices) · 2022-08-24
- ModerateKY Jelly Lubricant Recalled for Improper Storage Conditions
FDA (Devices) · 2022-08-24
- ModerateOTC Throat Lozenges Recalled for Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- HighSkin liquid bandage recalled for improper temperature storage
FDA (Devices) · 2022-08-24
- HighColgate Anticavity Fluoride Toothpaste Recalled for Improper Storage Conditions
FDA (Drugs) · 2022-09-07