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.
3 Class I (most serious) drug recalls reported in the last 30 days.
3,250 recalls
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Class II Ongoing
Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain — NDC 63181-0016
Reason: cGMP Deviations; product does not comply with cGMP requirements
Lots, distribution and details
- Lots / codes
- Lot code 51004101, exp 2/2020, lot 43394101, exp 11/2019, lot 33444101, exp 11/2018
- Distribution
- Distributed to following states: FL, PR, CO, GA.
- Quantity
- 459 bottles
- Recall started
- October 15, 2015 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0843-2016
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Class II Ongoing
Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0015-1, UPC 8 470003 244268
Reason: cGMP Deviations; product does not comply with cGMP requirements
Lots, distribution and details
- Lots / codes
- Lot code 40444601, exp 01/2019; Lot code 41414601, exp 05/2019; Lot code 40024602, exp 12/2018
- Distribution
- Distributed to following states: FL, PR, CO, GA.
- Quantity
- 542 bottles
- Recall started
- October 15, 2015 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0842-2016
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Class III Ongoing
Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
Lots, distribution and details
- Product
- Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02
- Lots / codes
- Lot 52-045-EV, Exp 07/1/2016
- Distribution
- Nationwide
- Quantity
- 103,600 vials
- Recall started
- March 15, 2016 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0836-2016
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Class III Ongoing
Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0…
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
Lots, distribution and details
- Product
- Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.
- Lots / codes
- Lot #: 56-853-FW, Exp 01AUG2017
- Distribution
- Nationwide and Hong Kong
- Quantity
- 10,778 bags
- Recall started
- February 2, 2016 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0727-2016
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Class I Ongoing
Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol/ methylcobalamin/pyridoxine/methionine/inositol/choline bitartrate USP) capsules, 60, 120 or 180 count vials, Glades Drugs, 109 S. Lake Ave.,…
Reason: Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
Lots, distribution and details
- Product
- Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol/ methylcobalamin/pyridoxine/methionine/inositol/choline bitartrate USP) capsules, 60, 120 or 180 count vials, Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476.
- Lots / codes
- AICACABF@3, AICECABF@2, AJBFCABF@4, ABCCABF@4, AICACABF@5, AICECABF@3, AJBHCABF@2, ABCCABF@5, AICBCABF@1, AICECABF@4, AJCBCABF@1, ABGCABF@4, AICBCABF@2, AICECABF@5, JCBCABF@2, BACDCABF@5, AICBCABF@3, AICICABF@3, BAAGCABF@2, BADACABF@3, AICBCABF@4, AJADCABF@1, BAAICABF@1, BACCABF@3, AICECABF@1, AJBECABF@6, BABCCABF@2 and BBAECABF@5, Exp 02/20/2016
- Distribution
- New York and Georgia
- Quantity
- 7800 capsules
- Recall started
- November 6, 2015 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0669-2016
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Class I Ongoing
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
Reason: Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.
Lots, distribution and details
- Product
- APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
- Lots / codes
- All lots
- Distribution
- All product is sold to Ace Distributors, LLC in Orlando, FL, a retail store, who sells directly to owners of gas stations, convenience stores, and smoke shops where it can be further distributed nationwide.
- Quantity
- 100,000 blister cards
- Recall started
- December 23, 2015 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0667-2016
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Class I Ongoing
Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle, Distributed by Life and More, L.L.C., Doral, Florida
Reason: Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.
Lots, distribution and details
- Lots / codes
- Lot # 000815004400; Exp 12/17
- Distribution
- Nationwide and Colombia, South America
- Quantity
- 783 bottles
- Recall started
- July 13, 2015 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0664-2016
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Class I Ongoing
MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.
Reason: Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product once contained in over-the-counter laxatives but was taken off the U.S. market due to safety concerns, making this product an unapproved drug.
Lots, distribution and details
- Lots / codes
- All lots through Expiration Date 04/15/2018
- Distribution
- Nationwide
- Quantity
- 1 bottle
- Recall started
- August 27, 2015 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0230-2016
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Class I Ongoing
MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 0911312397354.
Reason: Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug.
Lots, distribution and details
- Lots / codes
- All lots through Expiration Date 06/01/2018
- Distribution
- Nationwide
- Quantity
- 688 cartons
- Recall started
- August 27, 2015 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0229-2016
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Class III Ongoing
Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29
Reason: Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
Lots, distribution and details
- Lots / codes
- Lot 34-531-DK, Exp 10/01/2015
- Distribution
- Nationwide
- Quantity
- 24,100 Syringes
- Recall started
- September 29, 2015 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0054-2016
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Class II Ongoing
1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02
Reason: Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
Lots, distribution and details
- Lots / codes
- Lot #: 44-359-DK, Exp 08/01/2016
- Distribution
- Nationwide
- Quantity
- 100,200 Vials
- Recall started
- August 25, 2015 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1815-2015
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Class II Ongoing
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 — NDC 0409-3796-01 —- ALSO labeled under NOVAPLUS label NDC 0409-3796-49
Reason: Crystallization; identified as calcium salt of Ketorolac
Lots, distribution and details
- Lots / codes
- 31075DK, 31076DK, EXP01JUL2015; 32345DK, 32368DK, EXP 01AUG2015; 33152DK, EXP 01SEP2015; 34538DK, EXP 01OCT2015; 37227DK, EXP 01JAN2016, 41525DK, 42255DK, EXP 01MAY2016; 46042DK, 46045DK, 46048DK, 46304DK, 46305DK, 46432DK, 46433DK, EXP 01OCT2016 AND NOVAPLUS LOT 31074DK, EXP 01JUL2015
- Distribution
- Nationwide, Puerto Rico, Guam, Canada and Singapore
- Quantity
- 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)
- Recall started
- June 30, 2015 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1242-2015
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Class II Ongoing
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 — NDC 0409-3795-01 — Also labeled under NOVAPLUS label NDC 0409-3795-49
Reason: Crystallization; identified as calcium salt of Ketorolac
Lots, distribution and details
- Lots / codes
- 31077DK, 31078DK, 31338DK, 31339DK, 31340DK, EXP 01JUL2015; 32068DK, 32069DK, EXP 01AUG2915; 33270DK, EXP 01SEP2015; 34084DK, 34085DK, 34161DK, 34162DK, 34298DK, 34299DK, 34300DK, EXP 01OCT2015; 35011DK, 35081DK, 35082DK, 35116DK, EXP 01NOV2015; 38139DK, 38140DK, 36144DK, EXP 01FEB2016; 39256DK, 39257DK, EXP 01MAR2016; 42210DK, 42227DK, EXP01JUN2016; 43017DK, 43116DK, 43117DK, 43292DK, 43293DK, EXP 01JUL2016; 45034DK, 45035DK, 45118DK, 45120DK, EXP 01SEP2016; 46310DK, 46311DK, EXP 01OCT2016 AND NOVAPLUS LOTS 32106DK, 32220DK, 32221DK, EXP 01AUG2015; 33235DK, 33236DK, EXP 01SEP2015; 34163DK, 34164DK, EXP 01OCT2015; 39263DK, 39264DK, EXP 01MAR2016
- Distribution
- Nationwide, Puerto Rico, Guam, Canada and Singapore
- Quantity
- 12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label)
- Recall started
- June 30, 2015 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1241-2015
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Class II Ongoing
Ceftriaxone 1 gm/50 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29190, Discard After 05/23/14, Rx # 29068, Exp 05/18/14
Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lots, distribution and details
- Lots / codes
- Rx # 29190, Exp 05/23/14; Rx # 29068, Exp 05/18/14
- Distribution
- Florida
- Quantity
- 12 units
- Recall started
- May 15, 2014 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1482-2014
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Class II Ongoing
Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28879, Discard After 05/21/14
Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lots, distribution and details
- Lots / codes
- Rx # 28879, Exp 05/21/14
- Distribution
- Florida
- Quantity
- 11 units
- Recall started
- May 15, 2014 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1481-2014
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Class II Ongoing
Ceftriaxone 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29150, Discard After 05/17/14
Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lots, distribution and details
- Lots / codes
- Rx # 29150, Exp 05/17/14
- Distribution
- Florida
- Quantity
- 5 units
- Recall started
- May 15, 2014 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1480-2014
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Class II Ongoing
Cefepime 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29011, Discard After 05/21/14, Rx # 29141, Discard After 05/22/14, Rx # 29171, Discard After…
Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lots, distribution and details
- Product
- Cefepime 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29011, Discard After 05/21/14, Rx # 29141, Discard After 05/22/14, Rx # 29171, Discard After 05/20/14
- Lots / codes
- Rx # 29011, Exp 05/21/14; Rx # 29141, Exp 05/22/14; Rx # 29171, Exp 05/20/14
- Distribution
- Florida
- Quantity
- 52 units
- Recall started
- May 15, 2014 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1479-2014
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Class II Ongoing
Cubicin 700 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29083, Discard After 05/21/14
Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lots, distribution and details
- Lots / codes
- Rx # 29083, Exp 05/21/14
- Distribution
- Florida
- Quantity
- 7 units
- Recall started
- May 15, 2014 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1478-2014
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Class II Ongoing
Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29096, Discard After 05/20/14
Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lots, distribution and details
- Lots / codes
- Rx # 29096, Exp 05/20/14
- Distribution
- Florida
- Quantity
- 8 units
- Recall started
- May 15, 2014 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1477-2014
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Class II Ongoing
Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29175, Discard After 05/21/14; Rx # 28830, Discard After 05/17/14
Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lots, distribution and details
- Lots / codes
- Rx # 29175, Exp 05/21/14; Rx # 28830, Exp 05/17/14
- Distribution
- Florida
- Quantity
- 10 units
- Recall started
- May 15, 2014 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1476-2014
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Class II Ongoing
Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29185, Discard After 05/23/14
Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lots, distribution and details
- Lots / codes
- Rx # 29185, Exp 05/23/14
- Distribution
- Florida
- Quantity
- 14 units
- Recall started
- May 15, 2014 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1475-2014
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Class II Ongoing
Vancomycin 750 mg/150mL D5W,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28878, Discard After 05/16/14
Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lots, distribution and details
- Lots / codes
- Rx # 28878, Exp 05/16/14
- Distribution
- Florida
- Quantity
- 16 units
- Recall started
- May 15, 2014 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1474-2014
-
Class II Ongoing
Vancomycin 1.25 gm/250 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29140, Discard After 05/23/14
Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lots, distribution and details
- Lots / codes
- Rx # 29140, Exp 05/23/14
- Distribution
- Florida
- Quantity
- 14 units
- Recall started
- May 15, 2014 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1473-2014
-
Class II Ongoing
Vancomycin 1 gm/100 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29186, Discard After 05/22/14; Rx # 29010, Discard After 05/22/14
Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lots, distribution and details
- Lots / codes
- Rx # 29186, Exp 05/22/14; Rx # 29010, Exp 05/22/14
- Distribution
- Florida
- Quantity
- 21 units
- Recall started
- May 15, 2014 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1472-2014
-
Class II Ongoing
Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28503, Discard After 02/27/14
Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lots, distribution and details
- Lots / codes
- Rx # 28503, Exp 02/27/14
- Distribution
- Florida
- Quantity
- 14 units
- Recall started
- May 15, 2014 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1471-2014
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 November 5, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.