Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
51 recalls
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Class II Ongoing
Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-043-17
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-043-17
- Lots / codes
- Lot Code D54757, exp 3/31/2028
- Distribution
- CA, CO, FL, PR, WA
- Quantity
- 1401 tubes
- Recall started
- October 10, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0184-2026
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Class II Ongoing
Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02
- Lots / codes
- Lot Code D54596, exp 1/31/2028
- Distribution
- CA, CO, FL, PR, WA
- Quantity
- 1167 tubes
- Recall started
- October 10, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0183-2026
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Class II Ongoing
Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04
Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Lots, distribution and details
- Lots / codes
- All lots on or before expiry date 08/2027
- Distribution
- Nationwide in the USA
- Quantity
- 37,272 tubes
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0174-2026
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Class II Ongoing
Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- All lots within expiry.
- Distribution
- US Nationwide.
- Quantity
- —
- Recall started
- July 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0084-2026
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Class II Ongoing
Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- All lots within expiry.
- Distribution
- US Nationwide.
- Quantity
- 467
- Recall started
- July 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0070-2026
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Class II Ongoing
Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl. oz. per tube, Supreme Sunscreen SPF 50, 15 mL 0.5 fl. oz. per tube, Distributed by: Grace &…
Reason: Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Lots, distribution and details
- Product
- Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl. oz. per tube, Supreme Sunscreen SPF 50, 15 mL 0.5 fl. oz. per tube, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808, NDC 84803-110-01 (15 mL Velvet Screen), UPC 9355909005757.
- Lots / codes
- Lot #s: A2453, exp 11/30/2026; A2454, exp 12/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 44,497 tubes
- Recall started
- August 22, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0641-2025
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Class II Ongoing
Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC 84803-106-01, UPC 9355909006068, b) 50 mL, 1.7 fl. oz. per tube, NDC 84803-106-02, UPC 93559090059…
Reason: Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Lots, distribution and details
- Product
- Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC 84803-106-01, UPC 9355909006068, b) 50 mL, 1.7 fl. oz. per tube, NDC 84803-106-02, UPC 9355909005924, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808.
- Lots / codes
- Lot #s: a) 15 mL tubes: A2455, exp 12/31/2026; b) 50 mL tubes: A2453A, A2453B, exp 11/30/2026; A2454A, exp 12/31/2026; A2550, exp 02/28/2027
- Distribution
- Nationwide in the USA
- Quantity
- 49,275 tubes
- Recall started
- August 22, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0640-2025
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Class II Ongoing
In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingredients, Biodegradable & Baby Safe, 50 mL – 1.7 fl oz per bottle, Manufactured for IN YOUR FACE Skin…
Reason: cGMP deviations
Lots, distribution and details
- Product
- In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingredients, Biodegradable & Baby Safe, 50 mL – 1.7 fl oz per bottle, Manufactured for IN YOUR FACE Skin Care, Belleair Bluffs, FL, Made in USA, NDC: 73369-1601-1
- Lots / codes
- Lot: 408-002
- Distribution
- NJ, FL, MI
- Quantity
- 76 bottles
- Recall started
- March 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0515-2025
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Class II Ongoing
GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free, Biodegradable, Chemical Free, Non-Nano, Baby Safe, Original, SPF 32, Totally Green personal care,…
Reason: cGMP deviations
Lots, distribution and details
- Product
- GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free, Biodegradable, Chemical Free, Non-Nano, Baby Safe, Original, SPF 32, Totally Green personal care, Zinc Oxide USP 25%, 3.4 FL OZ/115 G Tube, NDC: 73369-0001-1
- Lots / codes
- Lots: 405-002 and 405-003
- Distribution
- NJ, FL, MI
- Quantity
- 174 tubes
- Recall started
- March 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0514-2025
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Class II Ongoing
Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1
Reason: cGMP deviations
Lots, distribution and details
- Product
- Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1
- Lots / codes
- Lot: 410-002
- Distribution
- NJ, FL, MI
- Quantity
- 54 tubes
- Recall started
- March 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0513-2025
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Class II Ongoing
B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1002-2; b) Tint Free Mineral Formula for Face…
Reason: cGMP deviations
Lots, distribution and details
- Product
- B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1002-2; b) Tint Free Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1001-2; c) Tan Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1003-2.
- Lots / codes
- Lots: a) 410-001, Exp 10/31/2027 b) 404-003, Exp 04/30/2027 c) 404-001, Exp 04/30/2027
- Distribution
- NJ, FL, MI
- Quantity
- 204 tubes
- Recall started
- March 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0512-2025
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Class II Terminated
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-440-02, UPC 8…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-440-02, UPC 8 10096 77162 9.
- Lots / codes
- Lot SP27A, Exp: 09/30/2026
- Distribution
- DE and NC
- Quantity
- 9,336 Tubes
- Recall started
- April 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0429-2025
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Class II Ongoing
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Rac…
Reason: Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Lots, distribution and details
- Product
- babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.
- Lots / codes
- Lot #: a) 097C4/C080316, Exp 03/31/2026; b) 177K3/A303407, Exp 10/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 57,184 bottles
- Recall started
- January 8, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0298-2025
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Class II Ongoing
Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 81…
Reason: Chemical Contamination
Lots, distribution and details
- Product
- Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 813277019916
- Lots / codes
- UPC 813277019916 Lot #: A033 / 5880343A, A054 / 2030633A, A058 / 2050633A, A058 / 2050633B, A058 / 2060633A, A058 / 2070633A, A058 / 2040633A, A059 / 2080633A, Exp. Date Feb-25; A314 / 4513223A, Exp. Date Nov-25; C054 / 2090774A, C057 / 2100774A, Exp. Date Feb-26; C131 / 3201394A, C131 / 3211394A, C131 / 3211394B, C131 / 3211394C, Exp. Date May-26 UPC 813277019923 Lot #: A060 / 3780693A, A060 / 3780693B, Exp. Date Mar-25; C067 / 2110774A, C067 / 2110774B, C067 / 2110774C, Exp. Date Mar-26; C169 / 7921734A, C169 / 7921734B, Exp. Date Jun-26
- Distribution
- Nationwide within the United States and Canada
- Quantity
- 493,462 units
- Recall started
- February 13, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0276-2025
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Class II Ongoing
Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930; Dist. by KAS Direct…
Reason: Chemical Contamination
Lots, distribution and details
- Product
- Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930; Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403.
- Lots / codes
- a) UPC 813277019954 Lot #: A034 / 5810343A, A034 / 5820343A, Exp. Date Feb-25; A282 / 0122853A, A289 / 0132853A, Exp. Date Oct-25; C010 / 1680174A, C011 / 1690174A, Exp. Date Jan-26; C218 / 2592224A, C218 / 2602224A, Exp. Date Aug-26. UPC 813277019800 Lot #: A142 / 3901443A, A142 / 3911443A, A142 / 3921443A, Exp. Date May-25; A278 / 0142843A, A279 / 0152843A, A279 / 0162843A, Exp. Date Oct-25; A314 / 4473263A, A314 / 4483263A, A317 / 4493263A, Exp. Date Nov-25; C046 / 0100594A, C047 / 0110594A C050 / 0120594A, Exp. Date Feb-26; C068 / 2770774A, C071 / 2790774A, Exp. Date Mar-26; C102 / 9621154A, C102 / 9621154B, C102 / 9621154C, Exp. Date Apr-26; C144 / 4721534A, C144 / 4731534A, C144 / 4741534A, C144 / 4751534A, Exp. Date May-26 b) UPC 813277019930 Lot #: A033 / 5830343A, Exp. Date Feb-25; A079 / 9620893A, A079 / 9630893A, Exp. Date Mar-25; A142 / 3881453A, A142 / 3891453A, Exp. Date May-25
- Distribution
- Nationwide within the United States and Canada
- Quantity
- 449,502 units
- Recall started
- February 13, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0275-2025
-
Class III Terminated
BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2
Reason: Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
Lots, distribution and details
- Lots / codes
- LOT# 091923A, Exp. Date 09/19/26
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 4,834 tins
- Recall started
- January 17, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0209-2025
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Class II Ongoing
Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%) packaged in 60 ml/2 fl oz, Vivier Canada Inc. / Mfd. for Vivier Pharma, Vaudereull-Dorion OC Canada, J7V 5V5, Champlain, NY USA 12919…
Reason: Microbial Contamination of Non-Sterile Product
Lots, distribution and details
- Product
- Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%) packaged in 60 ml/2 fl oz, Vivier Canada Inc. / Mfd. for Vivier Pharma, Vaudereull-Dorion OC Canada, J7V 5V5, Champlain, NY USA 12919, Made in Canada, NDC 67226-2232-6. SKU 10-160-ZZ-80059-R
- Lots / codes
- Lot #: 91771, Exp. Date 09/2025
- Distribution
- Nationwide within the United States
- Quantity
- 3476 units
- Recall started
- September 3, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0662-2024
-
Class II Ongoing
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, a) NDC: 69949-151-01, UPC: 854245006170 – IVORY b)…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, a) NDC: 69949-151-01, UPC: 854245006170 – IVORY b) NDC: 69949-156-01, UPC: 854245006224 – NUDE c) NDC: 69949-152-01, UPC: 854245006187 – BUFF d) NDC: 69949-153-01, UPC: 854245006194 – SAND e) NDC: 69949-155-01, UPC: 854245006217 – BRONZE f) NDC: 69949-157-01, UPC: 854245006446 – MOCHA
- Lots / codes
- Lot: a) 107IV, Exp: 04/30/2025 b) 107NU, Exp: 06/30/2025; 109NU, Exp: 10/31/2025 c) 117BU, Exp: 10/31/2025 d) 113SA, Exp: 06/30/2025; 114SA, Exp: 10/31/2025 e) 106BR, Exp: 04/30/2025; f) 101MO, Exp: 05/31/2025
- Distribution
- Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan
- Quantity
- 8202 tubes
- Recall started
- May 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0589-2024
-
Class I Ongoing
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187
Reason: Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Lots, distribution and details
- Product
- suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187
- Lots / codes
- Lot#: 115BU, Exp: 06/30/2025;
- Distribution
- Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan
- Quantity
- 1,902 tubes
- Recall started
- May 24, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0588-2024
-
Class II Ongoing
Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Squalene, Aloe, Dist. By: @…
Reason: Subpotent Drug: Product does not contain SPF that is declared on the label.
Lots, distribution and details
- Product
- Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Squalene, Aloe, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-002
- Lots / codes
- Lot #: 1752A, 1752B, 1782E, 1782G, 1782C, 1752C, 1782B; Exp. 06/2024.
- Distribution
- Nationwide in the USA, Spain, Italy, UK, and France.
- Quantity
- 2942 units
- Recall started
- August 18, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1176-2023
-
Class II Ongoing
Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 20…
Reason: Subpotent Drug: Product does not contain SPF that is declared on the label.
Lots, distribution and details
- Product
- Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-01
- Lots / codes
- Lot #: 1732A, 1732B, 1742A, 1742B, 1742C, 1742D; Exp. 06/2024.
- Distribution
- Nationwide in the USA, Spain, Italy, UK, and France.
- Quantity
- 5046 units
- Recall started
- August 18, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1175-2023
-
Class II Ongoing
Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Product
- Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0831-2023
-
Class II Ongoing
AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Product
- AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0788-2023
-
Class II Ongoing
Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35
Reason: CGMP Deviations:
Lots, distribution and details
- Product
- Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35
- Lots / codes
- Lot: Lot 1K64A, EXP 9/30/2023
- Distribution
- Nationwide in the USA
- Quantity
- 2,082 tubes
- Recall started
- October 13, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0145-2023
-
Class II Ongoing
Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy
- Lots / codes
- Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07262016A (01/22/2017), 07132016C (01/09/2017), 08302016A (02/26/2017), 08042016D (01/31/2017), 11012016K (04/30/2017), 09202016D (03/19/2017), 10032016B (04/01/2017), 08102016A (02/06/2017), 09282016D (03/27/2017), 09222016E (03/21/2017), 09152016A (02/28/2017), 09062016B (02/28/2017), 10252016C (02/28/2017), 10042016E (04/02/2017).
- Distribution
- Nationwide
- Quantity
- 1,544 vials
- Recall started
- November 17, 2016 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0301-2017
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.