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
-
Class II Ongoing
Calcium Gluconate 10% Injection (30 ML). Compounded by Tri-Coast Pharmacy
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Calcium Gluconate 10% Injection (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): 08172016A (02/13/2017).
- Distribution
- Nationwide
- Quantity
- 12 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-0254-2017
-
Class II Ongoing
BiMix Phentolamine/Papaverine 2 mg/30 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- BiMix Phentolamine/Papaverine 2 mg/30 mg/mL (1 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): 09302016D (11/14/2016).
- Distribution
- Nationwide
- Quantity
- 2 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-0253-2017
-
Class II Ongoing
BiMix Phentolamine/Papaverine 1 mg/30 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- BiMix Phentolamine/Papaverine 1 mg/30 mg/mL (1 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): 07222016H (09/05/2016)
- Distribution
- Nationwide
- Quantity
- 5 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-0252-2017
-
Class II Ongoing
BiMix Phentolamine/Papaverine 0.06 mg/1.8 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06092016B (0724/2016), 07212016C (09/04/2016), 09162016A (10/31/2016), 11012016A (12/16/2016).
- Distribution
- Nationwide
- Quantity
- 28 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-0251-2017
-
Class II Ongoing
B-Complex (30 ML), (Thiamine HCL 100 mg/Riboflavin-5-Phosphate 2 mg/Pyridoxine HCL 2 mg/Niacinamide 100 mg/Methylcobalamin 300 mcg/ml). Compounded by Tri-Coast Pharmacy.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07262016E (12/31/2016), 10262016E (02/28/2017).
- Distribution
- Nationwide
- Quantity
- 67 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-0250-2017
-
Class II Ongoing
BCAA (30 ML) (Isoleucine (L) 15 mg + Leucine (L) 10 mg+ Valine 40 mg+ Lidocaine HCL 10 mg/mL). Compounded by Tri-Coast Pharmacy.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- BCAA (30 ML) (Isoleucine (L) 15 mg + Leucine (L) 10 mg+ Valine 40 mg+ Lidocaine HCL 10 mg/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): 07222016A (01/18/2017), 08162016C (02/12/2017), 08042016A (01/31/2017), 11012016I (04/30/2017), 10172016B (02/28/2017).
- Distribution
- Nationwide
- Quantity
- 265 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-0249-2017
-
Class II Ongoing
Ascorbic Acid 500 mg/mL (50 ML). Compounded by Tri-Coast Pharmacy.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07192016WW (01/15/2017), 07152016G (01/11/2017), 08292016A (02/25/2017), 10262016B (02/28/2017).
- Distribution
- Nationwide
- Quantity
- 201 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-0248-2017
-
Class II Ongoing
Amino Acid Recover Eaze (50 ML), Phenylaline (L) 8 mg/ml + Tyrosine (L) 0.45 mg/ml + L-Taurine 0.7 mg/ml. Compounded by Tri-Coast Pharmacy.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Amino Acid Recover Eaze (50 ML), Phenylaline (L) 8 mg/ml + Tyrosine (L) 0.45 mg/ml + L-Taurine 0.7 mg/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): 06072016C (11/15/2016), 08162016E (09/08/2016).
- Distribution
- Nationwide
- Quantity
- 105 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-0247-2017
-
Class II Ongoing
Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25 mg/Methylcobalamin 300 mcg/Carnitine (L) 125 mg/Thiamine HCL 50 mg/Riboflavin-5-Phosphate Sod 5 mg/Niacinamide 20 mg/Pyridoxine HC…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25 mg/Methylcobalamin 300 mcg/Carnitine (L) 125 mg/Thiamine HCL 50 mg/Riboflavin-5-Phosphate Sod 5 mg/Niacinamide 20 mg/Pyridoxine HCL 2 mg/Folic Acid 2 mg/Ascorbic Acid 50 mg/Chromium Picolinate 200 mcg/Glutamine (L) 30 mg/Lidocaine HCL 10 mg/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): 06012016A (11/28/2016), 07282016A (12/31/2016).
- Distribution
- Nationwide
- Quantity
- 59 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-0246-2017
-
Class III Ongoing
INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide 3g, 28 capsules of topical tocopherol 5%, OTC, Manufactured for: Innocutis Holdings,…
Reason: Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
Lots, distribution and details
- Product
- INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide 3g, 28 capsules of topical tocopherol 5%, OTC, Manufactured for: Innocutis Holdings, LLC, Charleston, SC 29401, NDC 68712-013-01
- Lots / codes
- Lot #01316L02 6871201301
- Distribution
- AZ, CO and OH.
- Quantity
- 216 boxes
- Recall started
- December 6, 2016 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0237-2017
-
Class I Ongoing
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Reason: Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Lots, distribution and details
- Lots / codes
- Lot # 59064DK, Exp. 11/17
- Distribution
- Nationwide
- Quantity
- 143,250 vials
- Recall started
- August 4, 2016 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0218-2017
-
Class III Ongoing
Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30.
Reason: Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Lots, distribution and details
- Product
- Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30.
- Lots / codes
- Lot #: 1136091A, Incorrectly Labeled Exp: 03/18
- Distribution
- Nationwide and Puerto Rico
- Quantity
- 15,984 bottles
- Recall started
- August 30, 2016 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0118-2017
-
Class I Ongoing
Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180
Reason: Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.
Lots, distribution and details
- Lots / codes
- Lot 1220062085, Exp. 09/16
- Distribution
- Nationwide
- Quantity
- 70,350 capsules
- Recall started
- July 2, 2015 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-1165-2016
-
Class I Ongoing
Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 21…
Reason: Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
Lots, distribution and details
- Product
- Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
- Lots / codes
- Lot #: 50-343-DK*, Exp 01FEB2017; note that the lot number may be followed by numbers from 01 to 99.
- Distribution
- Nationwide, United Arab Emirates, Kuwait, and Bahrain
- Quantity
- 88,500 vials
- Recall started
- March 23, 2016 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-1137-2016
-
Class II Ongoing
LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufactured for Continuum Labs, Fort Lauderdale, FL
Reason: Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033
Lots, distribution and details
- Product
- LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufactured for Continuum Labs, Fort Lauderdale, FL
- Lots / codes
- Lot # 21511166, Exp 11/18
- Distribution
- Nationwide and Brazil.
- Quantity
- 3,319 bottles
- Recall started
- March 31, 2016 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0910-2016
-
Class I Ongoing
8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02
Reason: Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Lots, distribution and details
- Lots / codes
- Lot # 56-148-EV, Exp 8/1/2017
- Distribution
- Nationwide
- Quantity
- 72,000 units
- Recall started
- March 18, 2016 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0865-2016
-
Class III Ongoing
Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 21…
Reason: Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Lots, distribution and details
- Product
- Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
- Lots / codes
- Lot #: 42-335-DK, Exp 1JUN2016; 48-128-DK, 48-129-DK, 48-261-DK, 48-262-DK, 48-351-DK, Exp 1DEC2016; 52-361-DK, Exp 1APR2017; note that the lot number may be followed by numbers from 01 to 99.
- Distribution
- Nationwide, Puerto Rico, United Arab Emirates, Israel, Kuwait, Bahrain, and Trinidad & Tobago
- Quantity
- 715,200 vials
- Recall started
- March 23, 2016 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0854-2016
-
Class II Ongoing
Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252159
Reason: cGMP Deviations; product does not comply with cGMP requirements
Lots, distribution and details
- Product
- Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252159
- Lots / codes
- Lot code H04.2, exp 11/2019
- Distribution
- Distributed to following states: FL, PR, CO, GA.
- Quantity
- 44 compacts
- 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-0851-2016
-
Class II Ongoing
Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252166
Reason: cGMP Deviations; product does not comply with cGMP requirements
Lots, distribution and details
- Lots / codes
- Lot code H-04, exp 07/2019
- Distribution
- Distributed to following states: FL, PR, CO, GA.
- Quantity
- 45 compacts
- 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-0850-2016
-
Class II Ongoing
Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valenc…
Reason: cGMP Deviations; product does not comply with cGMP requirements
Lots, distribution and details
- Product
- Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1
- Lots / codes
- Lot code 51064901, exp 07/17; Lot code 51064902, exp 04/18
- Distribution
- Distributed to following states: FL, PR, CO, GA.
- Quantity
- 27 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-0849-2016
-
Class II Ongoing
Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0011-1
Reason: cGMP Deviations; product does not comply with cGMP requirements
Lots, distribution and details
- Lots / codes
- Lot code 51594901, exp 06/18,
- Distribution
- Distributed to following states: FL, PR, CO, GA.
- Quantity
- 66 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-0848-2016
-
Class II Ongoing
Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 16047-0029-1
Reason: cGMP Deviations; product does not comply with cGMP requirements
Lots, distribution and details
- Lots / codes
- Lot code 33454701, exp 11/18, lot 40424701, exp 1/2019
- Distribution
- Distributed to following states: FL, PR, CO, GA.
- Quantity
- 195 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-0847-2016
-
Class II Ongoing
Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0019-1 UPC 8 470002 075221
Reason: cGMP Deviations; product does not comply with cGMP requirements
Lots, distribution and details
- Lots / codes
- Lot code 40414701, exp 09/19; Lot code 33524701, exp 10/18; Lot code 40144101, exp 10/18
- Distribution
- Distributed to following states: FL, PR, CO, GA.
- Quantity
- 354 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-0846-2016
-
Class II Ongoing
Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Va…
Reason: cGMP Deviations; product does not comply with cGMP requirements
Lots, distribution and details
- Product
- Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0012-1 UPC8 429979 415691
- Lots / codes
- Lot code 41274901, exp 2/19.
- Distribution
- Distributed to following states: FL, PR, CO, GA.
- Quantity
- 20 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-0845-2016
-
Class II Ongoing
Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8…
Reason: cGMP Deviations; product does not comply with cGMP requirements
Lots, distribution and details
- Product
- Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707
- Lots / codes
- Lot code 41464901, exp 05/17
- Distribution
- Distributed to following states: FL, PR, CO, GA.
- Quantity
- 15 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-0844-2016
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.