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.
32 recalls
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Class II Ongoing
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- All lots within expiry
- Distribution
- CO
- Quantity
- approximate 50 to 60 bottles
- Recall started
- May 18, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0621-2026
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Class II Ongoing
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-08
Reason: Presence of a Foreign Substance; black particles observed in liquid
Lots, distribution and details
- Product
- Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-08
- Lots / codes
- Lot, expiry: Lots 26110722, 26110743, exp 9/8/2026; Lot 26111218, exp 9/9/2026
- Distribution
- OH
- Quantity
- 520 syringes
- Recall started
- May 1, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0549-2026
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Class II Ongoing
Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028;…
Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Lots, distribution and details
- Product
- Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028; MEN FRESH PETROLEUM JELLY, 100ML, 12CT, UPC: 60022127; d) Lucky Petroleum Jelly, 6 OZ, 12 PK, UPC: 808829081466;048155903562; e) Lucky Petroleum Jelly, COCOA, 6oz, 12ct, UPC: 808829081572, 048155922150; f) Personal Care, CREAMY PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155908642; g) Personal Care, CREAMY COCOA PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155922242; h) SOFTEE, PETROLEUM JELLY, 5oz, 12CT, UPC: 096002007208
- Lots / codes
- All lots within expiry distributed by Gold Star Distribution.
- Distribution
- US Nationwide.
- Quantity
- Unknown
- Recall started
- December 26, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0285-2026
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Class II Ongoing
Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M. CHERRY, 20 STK; f) BRAZIL, Cherry, 21CT/27.5G; f) LEMON. HONEY, 20CT #1180E; g) LIME FRESH,…
Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Lots, distribution and details
- Product
- Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M. CHERRY, 20 STK; f) BRAZIL, Cherry, 21CT/27.5G; f) LEMON. HONEY, 20CT #1180E; g) LIME FRESH, 20CT, #1182; h) MENTHOL BLUE, 20CT, #1180A; i) BRAZIL, Menthol, 21CT/27.5G, j) M . STRAWBERRY, 20 STK; k) DEFENSE, VITAMIN C, 20CT, #1181
- Lots / codes
- All lots within expiry distributed by Gold Star Distribution.
- Distribution
- US Nationwide.
- Quantity
- —
- Recall started
- December 26, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0278-2026
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Class II Ongoing
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl.…
Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Lots, distribution and details
- Product
- DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
- Lots / codes
- All lots on or before expiry date 08/2027
- Distribution
- Nationwide in the USA
- Quantity
- 7,736 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-0163-2026
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Class II Ongoing
Vitamin D3 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
- 339
- 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-0069-2026
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Class II Ongoing
Ascorbic Acid (Vitamin C) for Injection, Preserved, 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
- 1550
- 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-0041-2026
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Class II Ongoing
Ascorbic Acid (Vitamin C) for Injection, Preservative Free, 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
- 30
- 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-0040-2026
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Class I Ongoing
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Indu…
Reason: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Lots, distribution and details
- Product
- DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
- Lots / codes
- Lot # and Expiration Date: a) 30550A, Exp. Date 7/2025; 30670A, 30682A, Exp. Date 8/2025; 40025A, Exp. Date 1/2026; 40375A, Exp. Date 4/2026; 40427A, 40436A, Exp. Date 5/2026; 50068A, Exp. Date 1/2027. b)30586A, 30586B, 30626A, Exp. Date 7/2025; 30628A, 30657A, Exp. Date 8/2025; 30741A, Exp. Date 7/2025; 30871A, Exp. Date 10/2025; 40002A, Exp. Date 12/2025; 40012A, Exp. Date 1/2026; 40301A, Exp. Date 3/2026; 40789 A, Exp. Date 9/2026; 50068B, Exp. Date 1/2027; 50144A, 50149A, Exp. Date 2/2027.
- Distribution
- Nationwide within the USA
- Quantity
- 11,321 bag in boxes
- Recall started
- July 17, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0610-2025
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Class II Ongoing
Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, Manufactured for: Sandoz Inc., Princeton, NJ 08540, Distributed by Baxter Healthcare Corporation, Dee…
Reason: Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Lots, distribution and details
- Product
- Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, Manufactured for: Sandoz Inc., Princeton, NJ 08540, Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product of Canada, NDC 54643-5649-1
- Lots / codes
- Lot #: AA2279, Exp 8/31/26; AA2383, Exp 9/30/26
- Distribution
- Distributed to Medical Facilities in MS and FL.
- Quantity
- 15
- Recall started
- April 25, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0401-2025
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Class II Ongoing
Ergocalciferol – Vitamin D Supplement – 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302.
Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Lots, distribution and details
- Lots / codes
- Lot #: 24300812, Exp 01/31/2025; 24530836, Exp 07/19/2025
- Distribution
- Nationwide in the USA
- Quantity
- 3069 Oral Syringes
- Recall started
- February 17, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0250-2025
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Class II Ongoing
Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01
Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Lots, distribution and details
- Lots / codes
- Lot# 24A0050, exp. date 04/25/2026; 24A0055, exp. date 05/09/2026; 24A0059, exp. date 05/16/2026; 24A0060, exp. date 05/20/2026; 24A0071, exp. date 06/24/2026; 24A0072, exp. date 06/26/2026
- Distribution
- USA nationwide.
- Quantity
- 3139 boxes
- Recall started
- November 11, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0057-2025
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Class II Ongoing
Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01
Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Lots, distribution and details
- Lots / codes
- Lot# 24A0052, exp. date 05/01/2026; 24A0057, exp. date 05/13/2026; 24A0066, exp. date 05/31/2026; 24A0067, exp. date 06/04/2026; 24A0068, exp. date 06/17/2026; 24A0069, exp. date 06/19/2026 24A0075, exp. date 07/08/2026 24A0078, exp. date 07/12/2026
- Distribution
- USA nationwide.
- Quantity
- 7488 boxes
- Recall started
- November 11, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0056-2025
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Class II Terminated
Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
Reason: cGMP Deviations: Products were stored outside the drug label specifications.
Lots, distribution and details
- Lots / codes
- 519644
- Distribution
- Product was distributed to three direct accounts in NM, AZ and UT.
- Quantity
- 70 vials
- Recall started
- February 7, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0372-2024
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Class II Ongoing
Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- 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-0855-2023
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Class II Ongoing
SOFTSOAP ANTI BACTRIAL LQ SOAP 11.25 FLOZ SKU 2005090 DIAL LHS WHITE TEA AND VITAMIN E 7.5FLOZ SKU 2007700 SOFTSOAP LHS CC ANTIBAC ORANGE 50 FL OZ SKU 2007708 SPA SOAP ANTIBAC GLD LHS PUMP 20.2 FL OZ SKU 2097440 DIAL FOA…
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Product
- SOFTSOAP ANTI BACTRIAL LQ SOAP 11.25 FLOZ SKU 2005090 DIAL LHS WHITE TEA AND VITAMIN E 7.5FLOZ SKU 2007700 SOFTSOAP LHS CC ANTIBAC ORANGE 50 FL OZ SKU 2007708 SPA SOAP ANTIBAC GLD LHS PUMP 20.2 FL OZ SKU 2097440 DIAL FOAMING LHS POWER BERRIES 7.5 FL OZ SKU 2044098 SOFTSOAP LIQUID HAND SOAP FERSH CITRUS AB 11.25 FL OZ SKU 2005088 SPA SOAP HNDSP ANTBCTRL ULTR2X GLD 64 FL OZ SKU 2008290 DIAL FOAMING LHS SPRING WATER 7.5 FL OZ SKU 2044177 DAWN ULTRA ANTIBAC APL BLOSSOM 21.6 FLOZ SKU 1498425 DAWN ULTRA APPLE 15.5 FL OZ SKU 1414227 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Lots / codes
- SKUs: 1498425; 1414227; 2005090; 2007700; 2007708; 2097440; 2044098; 2005088; 2008290; 2044177
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1371-2022
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Class II Ongoing
Vitamin D3 50,000IU/mL, 10mL-vial, Room Temperature, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: 02252201A1, Exp 4/15/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 15 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1242-2022
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Class II Ongoing
Vitamin B-Complex Preservative Free, 3ml-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: 03112233B, Exp 5/10/2022
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 6 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1241-2022
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Class II Ongoing
Vitamin B-Complex, a) 10 mL-vial, b) 30 mL-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: a) 01252201A2, Exp 3/26/2022; b) 01252201A2, Exp 3/26/2022; 02032213A2, Exp 4/4/2022; 03042209A1, Exp 5/3/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 75 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1240-2022
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Class II Ongoing
Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96536 9
Reason: cGMP deviations: product stored outside of labeled temperature requirements.
Lots, distribution and details
- Lots / codes
- SKUs 2007626
- Distribution
- USA Nationwide
- Quantity
- N/A
- Recall started
- May 17, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0980-2022
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Class II Ongoing
Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Aloe Vera, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96537 6
Reason: cGMP deviations: product stored outside of labeled temperature requirements.
Lots, distribution and details
- Product
- Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Aloe Vera, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96537 6
- Lots / codes
- SKUs 2007625
- Distribution
- USA Nationwide
- Quantity
- N/A
- Recall started
- May 17, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0979-2022
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Class II Ongoing
Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico, UPC 639277928597
Reason: CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Lots, distribution and details
- Lots / codes
- 1931101AL
- Distribution
- USA Nationwide
- Quantity
- 19,992 bottles
- Recall started
- July 30, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0081-2021
-
Class II Ongoing
Vitamin D3 100,000 Unit/mL, in olive oil, (30 ML). Compounded by Tri-Coast Pharmacy
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Vitamin D3 100,000 Unit/mL, in olive oil, (30 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): 06062016E (10/26/2016), 08152016C (02/11/2017), 10042016A (03/02/2017), 07282016D (01/24/2017), 09092016A (03/02/2016).
- Distribution
- Nationwide
- Quantity
- 662 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-0325-2017
-
Class II Ongoing
Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosp…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg + Folic Acid 1 mg + Vitamin E Succinate 10 IU + Vitamin A Acetate 100 IU/10-mL), (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): 07182016A (12/31/2016)
- Distribution
- Nationwide
- Quantity
- 21 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-0275-2017
-
Class II Ongoing
IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phy…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL), (30 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, if known): 05252016D (05/28/2016), 05202016A (05/23/2016), 05182016C (05/21/2016), 05092016C (05/12/2016), 05022016C (05/05/2016), 06132016D (06/16/2016), 06072016A (06/10/2016), 06062016A (06/09/2016), 07282106E (07/31/2016), 07252016G (07/28/2016), 09122016A (09/15/2016), 09192016B (09/22/2016)
- Distribution
- Nationwide
- Quantity
- 132 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-0265-2017
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.