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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

Daye Tampons and Product Bundles Recalled for Lack of FDA Clearance

Agency Publication Date: October 28, 2025
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Summary

Daye (Anne's Day Ltd) has voluntarily recalled approximately 3,074 packs of various tampon products and bundles because they were sold without the required FDA 510(k) clearance. The recall includes Coated and Nude tampons in both Regular and Super sizes, along with various trial boxes, refill bundles, and initiation sets. These medical devices have not been reviewed by the FDA for safety or effectiveness, though no incidents or injuries have been reported to date.

Risk

Products sold without FDA clearance have not been evaluated for safety, quality, or performance standards. This lack of regulatory review means there is no verification that the materials and manufacturing processes are safe for consumer use.

What You Should Do

  1. Daye (Anne's Day Ltd) has recalled several tampon products including 'Coated Super,' 'Nude Super,' 'Coated Regular,' and 'Nude Regular' varieties sold individually, in refills, or as part of trial boxes and flow bundles.
  2. Check your product packaging for affected model numbers such as FG-TMP-RET00090009, FG-TMP-RET09000900, FG-TMP-REF18000000, and others including refill and initiation kit variants.
  3. Verify the lot number on your packaging against the extensive list of affected codes, which includes strings beginning with 20CR, 20CS, CR00, and CS00. See the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled tampons immediately.
  5. Return the product to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or Daye (Anne's Day Ltd) for further instructions.
  6. Contact Daye (Anne's Day Ltd) directly through their customer service channels or via the notification email sent to purchasers.
  7. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Stop using and throw the product away.

Affected Products

Product: 9 Coated Super Tampons and 9 Nude Super Tampons
Variants: Super, Coated, Nude
Model / REF:
FG-TMP-RET00090009
Lot Numbers (91):
20CR0014
20CS0034
20CS0037
20CS0038
20CS0039
20CS0040
20CS0041
CR001597
CR001598
CR001599
CR001616
CR001616NR001893
CR001617
CR001617CS002165
CR001617NR001844ST23/R/3001-0523ADL
CR001617NR001902
CR001619
CR001623
CR001625
CR001625NR001844ST23/R/3001-0523ADL
CR001626
CR001627
CR001629
CR001633
CR001636
CR001638
CR001640
CR001643
CR001645
CR001655
CR001661
CR001662
CR003000
CR003001
CR003002
CR003005
CR003008
CR003009
CR003020
CR003022
CR003027
CR003031
CR003032
CR003038
CS002088
CS002119
CS002120
CS002121
CS002122
CS002143
UDI:
05060994740608

Quantity: 3074 packs

Product: 9 Coated Regular Tampons and 9 Nude Regular Tampons
Variants: Regular, Coated, Nude
Model / REF:
FG-TMP-RET09000900
Lot Numbers (91):
20CR0014
20CS0034
20CS0037
20CS0038
20CS0039
20CS0040
20CS0041
CR001597
CR001598
CR001599
CR001616
CR001616NR001893
CR001617
CR001617CS002165
CR001617NR001844ST23/R/3001-0523ADL
CR001617NR001902
CR001619
CR001623
CR001625
CR001625NR001844ST23/R/3001-0523ADL
CR001626
CR001627
CR001629
CR001633
CR001636
CR001638
CR001640
CR001643
CR001645
CR001655
CR001661
CR001662
CR003000
CR003001
CR003002
CR003005
CR003008
CR003009
CR003020
CR003022
CR003027
CR003031
CR003032
CR003038
CS002088
CS002119
CS002120
CS002121
CS002122
CS002143
UDI:
05060994740592

Quantity: 3074 packs

Product: 18 Coated Regular Tampons
Variants: Regular, Coated
Model / REF:
FG-TMP-REF18000000
Lot Numbers (91):
20CR0014
20CS0034
20CS0037
20CS0038
20CS0039
20CS0040
20CS0041
CR001597
CR001598
CR001599
CR001616
CR001616NR001893
CR001617
CR001617CS002165
CR001617NR001844ST23/R/3001-0523ADL
CR001617NR001902
CR001619
CR001623
CR001625
CR001625NR001844ST23/R/3001-0523ADL
CR001626
CR001627
CR001629
CR001633
CR001636
CR001638
CR001640
CR001643
CR001645
CR001655
CR001661
CR001662
CR003000
CR003001
CR003002
CR003005
CR003008
CR003009
CR003020
CR003022
CR003027
CR003031
CR003032
CR003038
CS002088
CS002119
CS002120
CS002121
CS002122
CS002143
UDI:
05060994741148

Quantity: 3074 packs

Product: 18 Coated Super Tampons
Variants: Super, Coated
Model / REF:
FG-TMP-REF00180000
Lot Numbers (91):
20CR0014
20CS0034
20CS0037
20CS0038
20CS0039
20CS0040
20CS0041
CR001597
CR001598
CR001599
CR001616
CR001616NR001893
CR001617
CR001617CS002165
CR001617NR001844ST23/R/3001-0523ADL
CR001617NR001902
CR001619
CR001623
CR001625
CR001625NR001844ST23/R/3001-0523ADL
CR001626
CR001627
CR001629
CR001633
CR001636
CR001638
CR001640
CR001643
CR001645
CR001655
CR001661
CR001662
CR003000
CR003001
CR003002
CR003005
CR003008
CR003009
CR003020
CR003022
CR003027
CR003031
CR003032
CR003038
CS002088
CS002119
CS002120
CS002121
CS002122
CS002143
UDI:
05060994741179

Quantity: 3074 packs

Product: 9 Coated Regular and 9 Coated Super Tampons
Variants: Regular, Super, Coated
Model / REF:
FG-TMP-REF09090000
Lot Numbers (91):
20CR0014
20CS0034
20CS0037
20CS0038
20CS0039
20CS0040
20CS0041
CR001597
CR001598
CR001599
CR001616
CR001616NR001893
CR001617
CR001617CS002165
CR001617NR001844ST23/R/3001-0523ADL
CR001617NR001902
CR001619
CR001623
CR001625
CR001625NR001844ST23/R/3001-0523ADL
CR001626
CR001627
CR001629
CR001633
CR001636
CR001638
CR001640
CR001643
CR001645
CR001655
CR001661
CR001662
CR003000
CR003001
CR003002
CR003005
CR003008
CR003009
CR003020
CR003022
CR003027
CR003031
CR003032
CR003038
CS002088
CS002119
CS002120
CS002121
CS002122
CS002143
UDI:
05060994741209

Quantity: 3074 packs

Product: 9 Coated Regular and 9 Nude Regular Tampons
Variants: Regular, Coated, Nude
Model / REF:
FG-TMP-REF09000900
Lot Numbers (91):
20CR0014
20CS0034
20CS0037
20CS0038
20CS0039
20CS0040
20CS0041
CR001597
CR001598
CR001599
CR001616
CR001616NR001893
CR001617
CR001617CS002165
CR001617NR001844ST23/R/3001-0523ADL
CR001617NR001902
CR001619
CR001623
CR001625
CR001625NR001844ST23/R/3001-0523ADL
CR001626
CR001627
CR001629
CR001633
CR001636
CR001638
CR001640
CR001643
CR001645
CR001655
CR001661
CR001662
CR003000
CR003001
CR003002
CR003005
CR003008
CR003009
CR003020
CR003022
CR003027
CR003031
CR003032
CR003038
CS002088
CS002119
CS002120
CS002121
CS002122
CS002143
UDI:
05060994741230

Quantity: 3074 packs

Product: 9 Coated Super and 9 Nude Super Tampons
Variants: Super, Coated, Nude
Model / REF:
FG-TMP-REF00090009
Lot Numbers (91):
20CR0014
20CS0034
20CS0037
20CS0038
20CS0039
20CS0040
20CS0041
CR001597
CR001598
CR001599
CR001616
CR001616NR001893
CR001617
CR001617CS002165
CR001617NR001844ST23/R/3001-0523ADL
CR001617NR001902
CR001619
CR001623
CR001625
CR001625NR001844ST23/R/3001-0523ADL
CR001626
CR001627
CR001629
CR001633
CR001636
CR001638
CR001640
CR001643
CR001645
CR001655
CR001661
CR001662
CR003000
CR003001
CR003002
CR003005
CR003008
CR003009
CR003020
CR003022
CR003027
CR003031
CR003032
CR003038
CS002088
CS002119
CS002120
CS002121
CS002122
CS002143
UDI:
05060994741261

Quantity: 3074 packs

Product: Trial Tampon Box
Model / REF:
FG-TMP-REF04050504
Lot Numbers (91):
20CR0014
20CS0034
20CS0037
20CS0038
20CS0039
20CS0040
20CS0041
CR001597
CR001598
CR001599
CR001616
CR001616NR001893
CR001617
CR001617CS002165
CR001617NR001844ST23/R/3001-0523ADL
CR001617NR001902
CR001619
CR001623
CR001625
CR001625NR001844ST23/R/3001-0523ADL
CR001626
CR001627
CR001629
CR001633
CR001636
CR001638
CR001640
CR001643
CR001645
CR001655
CR001661
CR001662
CR003000
CR003001
CR003002
CR003005
CR003008
CR003009
CR003020
CR003022
CR003027
CR003031
CR003032
CR003038
CS002088
CS002119
CS002120
CS002121
CS002122
CS002143
UDI:
5060994741292

Quantity: 3074 packs

Product: All in One Bundle
Model / REF:
FG-BNDL-PC-REFAIO
Lot Numbers (91):
20CR0014
20CS0034
20CS0037
20CS0038
20CS0039
20CS0040
20CS0041
CR001597
CR001598
CR001599
CR001616
CR001616NR001893
CR001617
CR001617CS002165
CR001617NR001844ST23/R/3001-0523ADL
CR001617NR001902
CR001619
CR001623
CR001625
CR001625NR001844ST23/R/3001-0523ADL
CR001626
CR001627
CR001629
CR001633
CR001636
CR001638
CR001640
CR001643
CR001645
CR001655
CR001661
CR001662
CR003000
CR003001
CR003002
CR003005
CR003008
CR003009
CR003020
CR003022
CR003027
CR003031
CR003032
CR003038
CS002088
CS002119
CS002120
CS002121
CS002122
CS002143
UDI:
5060994741575

Quantity: 3074 packs

Product: Refill 3 Month Heavy Flow Bundle
Variants: Heavy Flow, Refill
Model / REF:
FG-BNDL-PC-MM-REFHF
Lot Numbers (91):
20CR0014
20CS0034
20CS0037
20CS0038
20CS0039
20CS0040
20CS0041
CR001597
CR001598
CR001599
CR001616
CR001616NR001893
CR001617
CR001617CS002165
CR001617NR001844ST23/R/3001-0523ADL
CR001617NR001902
CR001619
CR001623
CR001625
CR001625NR001844ST23/R/3001-0523ADL
CR001626
CR001627
CR001629
CR001633
CR001636
CR001638
CR001640
CR001643
CR001645
CR001655
CR001661
CR001662
CR003000
CR003001
CR003002
CR003005
CR003008
CR003009
CR003020
CR003022
CR003027
CR003031
CR003032
CR003038
CS002088
CS002119
CS002120
CS002121
CS002122
CS002143
UDI:
5060994741629

Quantity: 3074 packs

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97718
Status: Active
Manufacturer: DAYE (ANNE'S DAY LTD)
Sold By: Direct distribution; Retail packs
Manufactured In: United Kingdom
Units Affected: 29 products (3074 packs)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.