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.
1,070 recalls
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Class III Ongoing
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Lots, distribution and details
- Product
- Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
- Lots / codes
- Lot#: 1027583, Exp 09/30/2027
- Distribution
- USA Nationwide
- Quantity
- 63,500 tablets
- Recall started
- May 1, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0536-2026
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Class III Ongoing
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Lots, distribution and details
- Lots / codes
- Lot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028.
- Distribution
- USA Nationwide
- Quantity
- 44865 bottles
- Recall started
- April 24, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0533-2026
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Class II Ongoing
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.
- Lots / codes
- Lot # 25140859; Exp. Date: Jan 2027
- Distribution
- U.S. Nationwide
- Quantity
- 17,304 100-count bottles
- Recall started
- April 27, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0547-2026
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Class II Ongoing
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16
Reason: Chemical contamination; presence of lead and lithium above specification
Lots, distribution and details
- Product
- NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16
- Lots / codes
- Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
- Distribution
- Nationwide
- Quantity
- 6,336 bottles
- Recall started
- April 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0523-2026
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Class II Ongoing
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pha…
Reason: Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Lots, distribution and details
- Product
- Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.
- Lots / codes
- Lot #: GEH25023, Expires: 6/30/2027
- Distribution
- Nationwide in the USA
- Quantity
- 675 bottles
- Recall started
- April 23, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0520-2026
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Class III Ongoing
Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950
Reason: Failed PH Specifications
Lots, distribution and details
- Lots / codes
- Lots: A5014, A5018, A5019
- Distribution
- Nationwide in the USA
- Quantity
- 31,488 tubes
- Recall started
- April 7, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0509-2026
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Class II Ongoing
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11
Reason: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Lots, distribution and details
- Lots / codes
- Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.
- Distribution
- Nationwide within the United States
- Quantity
- —
- Recall started
- April 23, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0501-2026
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Class II Ongoing
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11
Reason: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Lots, distribution and details
- Lots / codes
- Lot#: 3T36B, Exp. Date October 31, 2026.
- Distribution
- Nationwide within the United States
- Quantity
- —
- Recall started
- April 23, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0500-2026
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Class II Ongoing
GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.
Reason: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Lots, distribution and details
- Lots / codes
- Lot #: 9T20, 9T50, 9T59, 1U30, 1U48, Exp Date: 4/30/2026; 4V15, Exp Date: 8/31/2026; 7V61, Exp Date: 12/31/2026; 1W47, 1W49, 1X14, Exp Date: 3/31/2027.
- Distribution
- Nationwide within the United States
- Quantity
- —
- Recall started
- April 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0492-2026
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Class II Ongoing
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
Reason: Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Lots, distribution and details
- Product
- Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
- Lots / codes
- Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 2,238 5 x 10 unit dose cartons
- Recall started
- April 9, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0493-2026
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Class II Ongoing
Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton)
- Lots / codes
- All lots within expiry
- Distribution
- USA Nationwide.
- Quantity
- N/A
- Recall started
- April 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0532-2026
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Class II Ongoing
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules)
- Lots / codes
- All lots within expiry
- Distribution
- USA Nationwide.
- Quantity
- 3,260,170 ampules
- Recall started
- April 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0530-2026
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Class II Ongoing
Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by:…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton)
- Lots / codes
- All lots within expiry
- Distribution
- USA Nationwide.
- Quantity
- 33,599,925 ampules and 23658125 vials
- Recall started
- April 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0529-2026
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Class II Ongoing
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61
- Lots / codes
- Lot # N02425, Exp Date: 05/31/2027.
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- March 24, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0485-2026
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Class III Terminated
Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05
- Lots / codes
- Lot 4212D4; Exp. 07/31/2026
- Distribution
- U.S. Nationwide
- Quantity
- 299 bottles
- Recall started
- March 18, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0482-2026
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Class III Terminated
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04
- Lots / codes
- Lot 4212D2; Exp. 07/03/2026
- Distribution
- U.S. Nationwide
- Quantity
- 2895 bottles
- Recall started
- March 18, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0481-2026
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Class III Terminated
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
- Lots / codes
- Lot 4155D2, 4155D3; Exp. 05/15/2026
- Distribution
- U.S. Nationwide
- Quantity
- 1060 bottles
- Recall started
- March 18, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0480-2026
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Class II Ongoing
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-620-30, UPC: 635515999411.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Lots, distribution and details
- Lots / codes
- Lot # 20240720, Exp Date: 07/20/2026.
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- March 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0470-2026
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Class II Ongoing
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-675-30, UPC: 635515986718.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Lots, distribution and details
- Lots / codes
- Lot # 20240720, Exp Date: 07/20/2026; Lot # 20240524, Exp Date: 05/24/2026.
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- March 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0469-2026
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Class II Ongoing
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-617-30, UPC: 63551598673.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Lots, distribution and details
- Lots / codes
- Lot # 20240720, Exp Date: 07/20/2026.
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- March 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0468-2026
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Class II Ongoing
QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-625-30, UPC: 635515999398.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Lots, distribution and details
- Lots / codes
- Lot # 20240720, Exp Date: 07/20/2026.
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- March 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0467-2026
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Class II Ongoing
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Lots, distribution and details
- Lots / codes
- Lot # 20240720, Exp Date: 07/20/2026, Lot # 20241030, Exp Date: 10/30/2026.
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- March 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0466-2026
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Class II Ongoing
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Lots, distribution and details
- Lots / codes
- Lot # 20240524, Exp Date: 05/24/2026; Lot # 20240720, Exp Date: 07/20/2026.
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- March 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0465-2026
-
Class II Ongoing
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Black Cherry Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Lots, distribution and details
- Lots / codes
- Lot# 20240720, Exp Date: 07/20/2026.
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- March 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0464-2026
-
Class II Ongoing
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-80, UPC: 38317300…
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Lots, distribution and details
- Product
- MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-80, UPC: 383173000030.
- Lots / codes
- Lot# 20240730, Exp Date: 07/30/2026.
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- March 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0463-2026
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 1, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.