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
GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lots, distribution and details
- Lots / codes
- Lot #1030202010, Exp 11/30/2020
- Distribution
- CA, CO, FL, IN, KY, OH, TX
- Quantity
- 1 vial
- Recall started
- November 30, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0141-2021
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Class II Ongoing
THYMOSIN BETA – 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lots, distribution and details
- Lots / codes
- Lot #1110202005, Exp 12/10/2020; Lot #1102202015, Exp 12/08/2020; Lot #1105202009, Exp 12/20/2020
- Distribution
- CA, CO, FL, IN, KY, OH, TX
- Quantity
- 3 vials
- Recall started
- November 30, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0140-2021
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Class II Ongoing
CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lots, distribution and details
- Lots / codes
- Lot #1110202004 Exp 12/10/2020
- Distribution
- CA, CO, FL, IN, KY, OH, TX
- Quantity
- 1 vial
- Recall started
- November 30, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0139-2021
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Class II Ongoing
DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lots, distribution and details
- Lots / codes
- Lot #1111202002, Exp 12/11/2020
- Distribution
- CA, CO, FL, IN, KY, OH, TX
- Quantity
- 1 vial
- Recall started
- November 30, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0138-2021
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Class II Ongoing
B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lots, distribution and details
- Lots / codes
- Lot #1111202001, Exp 01/11/2021
- Distribution
- CA, CO, FL, IN, KY, OH, TX
- Quantity
- 1 vials
- Recall started
- November 30, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0137-2021
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Class II Ongoing
NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lots, distribution and details
- Lots / codes
- Lot #1113202002, Exp 01/13/2021; Lot #1102202005, Exp 12/08/2020
- Distribution
- CA, CO, FL, IN, KY, OH, TX
- Quantity
- 2 vials
- Recall started
- November 30, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0136-2021
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Class II Ongoing
GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lots, distribution and details
- Lots / codes
- Lot #1112202008, Exp 12/11/2020
- Distribution
- CA, CO, FL, IN, KY, OH, TX
- Quantity
- 1 vial
- Recall started
- November 30, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0135-2021
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Class II Ongoing
IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lots, distribution and details
- Lots / codes
- Lot # 1029202005,Exp 11/29/2020; Lot #1102202014, Exp 12/08/2020; Lot #1112202002, Exp 12/12/2020
- Distribution
- CA, CO, FL, IN, KY, OH, TX
- Quantity
- 3 vials
- Recall started
- November 30, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0134-2021
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Class II Ongoing
THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lots, distribution and details
- Lots / codes
- Lot #110220200, 1102202009, Exp 12/09/2020; Lot #1105202009, Exp 12/20/2020; Lot #1110202008, Exp 12/10/2020
- Distribution
- CA, CO, FL, IN, KY, OH, TX
- Quantity
- 4 vials
- Recall started
- November 30, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0133-2021
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Class II Ongoing
BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lots, distribution and details
- Lots / codes
- Lot #1102202009, Exp 12/08/2020; Lot #1105202009, Exp 12/20/2020; Lot #1110202001, Exp 12/15/2020; Lot #1112202004, Exp 12/12/2020
- Distribution
- CA, CO, FL, IN, KY, OH, TX
- Quantity
- 4 vials
- Recall started
- November 30, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0132-2021
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Class II Ongoing
AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lots, distribution and details
- Lots / codes
- Lot #1029202003, Exp 11/29/2020; Lot #1110202002, Exp 12/10/2020; Lot #1112202001, Exp 12/12/2020
- Distribution
- CA, CO, FL, IN, KY, OH, TX
- Quantity
- 3 vials
- Recall started
- November 30, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0131-2021
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Class II Ongoing
PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lots, distribution and details
- Lots / codes
- Lot #1112202006, Exp 12/12/2020
- Distribution
- CA, CO, FL, IN, KY, OH, TX
- Quantity
- 1 vial
- Recall started
- November 30, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0130-2021
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Class II Ongoing
FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lots, distribution and details
- Lots / codes
- Lot #1112202006, Exp 12/12/2020
- Distribution
- CA, CO, FL, IN, KY, OH, TX
- Quantity
- 1 vial
- Recall started
- November 30, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0129-2021
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Class II Ongoing
CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lots, distribution and details
- Lots / codes
- Lot #1029202004, Exp 11/29/2020; Lot #1102202001, 102202009, Exp 12/08/2020; Lot #1105202009, Exp 12/20/2020; Lot #1110202003, Exp 12/10/2020; Lot #1112202004, Exp 12/12/2020
- Distribution
- CA, CO, FL, IN, KY, OH, TX
- Quantity
- 6 vials
- Recall started
- November 30, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0128-2021
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Class II Ongoing
NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by: Genomma Lab USA Inc., Houston, TX 77027. UPC 6 50240 05357 3
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
- Lots ending in 1001,1002, 1003, 1004, 1005.
- Distribution
- USA Nationwide
- Quantity
- 4,598,788 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-0082-2021
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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
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Class II Ongoing
Assured Instant Hand Sanitizer Aloe & Moisturizers (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 639277928610
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
- 1931102AL
- Distribution
- USA Nationwide
- Quantity
- 27,000 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-0080-2021
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Class II Ongoing
Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8 fl oz (237 mL) bottle, Distributed by: Midwood brands, LLC 10611 Monroe RD. Mathews, NC 28105 Made in Mexico UPC 3 2251 38042 6
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
- 1931104AL
- Distribution
- USA Nationwide
- Quantity
- 2,760 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-0079-2021
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Class II Ongoing
NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620…
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
- Product
- NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620 00017 5
- Lots / codes
- all lots
- Distribution
- USA Nationwide
- Quantity
- 1,441,548 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-0078-2021
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Class II Ongoing
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01
Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Lots, distribution and details
- Lots / codes
- MET100201, MET100401 EXP 05/2022
- Distribution
- Nationwide
- Quantity
- 20,872 bottles
- Recall started
- October 23, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0068-2021
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Class II Ongoing
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01
Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Lots, distribution and details
- Lots / codes
- MET200101, MET200301 EXP 05/2022
- Distribution
- Nationwide
- Quantity
- 12,967 bottles
- Recall started
- October 23, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0067-2021
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Class II Ongoing
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs In…
Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Lots, distribution and details
- Product
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131
- Lots / codes
- a) 30 count: N107051905, exp 10/31/2020; N107052002, N107052005, exp 9/30/2021 b) 60 count: N107051907, exp 10/31/2020; N107052001 6/30/2021; N107052010, N107052008, N107052004, exp 9/30/2021; c) 90 count: C107051908, exp 10/31/2020, C107052002, C107051909 exp 6/30/2021, C107052001, exp 12/31/2020, C107052004, N107052006, N107052007, N107052009, N107052011, N107052012 exp 9/30/2021; d) 120 count: C107051907, N107051904, N107051906 exp 10/31/2020 C107051910, exp 6/30/2021; C107052003, C107052005, N107052003 exp 9/30/2021
- Distribution
- Indiana – Nationwide.
- Quantity
- a) 684; b) 432; c) 3668; d) 2029 bottles
- Recall started
- October 8, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0057-2021
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Class II Ongoing
Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Lots, distribution and details
- Product
- Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
- Lots / codes
- N107411901, N107411903, N107411904, N107411905, N107411906, exp 11/30/2020; N107411907, N107412001, exp 4/30/2021; N107412002, N107412004, exp 11/30/2021; N107412003, exp 7/31/2021
- Distribution
- Indiana – Nationwide.
- Quantity
- N/A
- Recall started
- October 8, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0056-2021
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Class II Ongoing
Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC 20009, NDC 74625-003-05, UPC 74…
Reason: Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
Lots, distribution and details
- Product
- Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC 20009, NDC 74625-003-05, UPC 7401037203427.
- Lots / codes
- Lot #s: 36748, 36818, 36697, Exp. 10/15/21 and 11/8/21
- Distribution
- Nationwide in the U.S.
- Quantity
- 8600 bottles
- Recall started
- September 11, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0041-2021
-
Class II Ongoing
Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC, 20009, NDC 74625-003-04, UPC 74010…
Reason: Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
Lots, distribution and details
- Product
- Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC, 20009, NDC 74625-003-04, UPC 7401037203250.
- Lots / codes
- Lot #s: 36748, 36818, 36697, Exp. 10/15/21 and 11/8/21
- Distribution
- Nationwide in the U.S.
- Quantity
- 5,320 bottles
- Recall started
- September 11, 2020 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0040-2021
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.