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.
3,228 recalls
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Class II Ongoing
FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., NDC 55319-171-68.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Lots, distribution and details
- Lots / codes
- Lot #: 1716089, expires: JAN 2029.
- Distribution
- U.S.A. Nationwide
- Quantity
- —
- Recall started
- May 28, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0568-2026
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Class II Ongoing
DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets, Distributed by: Drug Mart- Food Fair Medina, OH 44256, UPC: 0 93351 03992 8.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Lots, distribution and details
- Lots / codes
- Lot #: 1276118, Exp 1/31/2029.
- Distribution
- U.S.A. Nationwide
- Quantity
- —
- Recall started
- May 28, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0567-2026
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Class II Ongoing
CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-178-23.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Lots, distribution and details
- Lots / codes
- Lot #: 1716259, Exp 3/31/2029.
- Distribution
- U.S.A. Nationwide
- Quantity
- —
- Recall started
- May 28, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0566-2026
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Class II Ongoing
CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-127-80.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Lots, distribution and details
- Lots / codes
- Lot #: 1276118, 1276119, expires: JAN 2029.
- Distribution
- U.S.A. Nationwide
- Quantity
- —
- Recall started
- May 28, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0565-2026
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Class II Ongoing
MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, Distributed by: De Moules Supermarkets, Inc.,Tewksbury, Mass 01875, UPC 0 49705 83149 6.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Lots, distribution and details
- Product
- MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, Distributed by: De Moules Supermarkets, Inc.,Tewksbury, Mass 01875, UPC 0 49705 83149 6.
- Lots / codes
- Lot #: 1716089, expires: JAN 2029.
- Distribution
- U.S.A. Nationwide
- Quantity
- —
- Recall started
- May 28, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0564-2026
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Class II Ongoing
24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 mg, 96 chewable tablets, DISTRIBUTED BY 7-ELEVEN, IRVING, TX 75063, UPC 0 5254863573 2.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Lots, distribution and details
- Lots / codes
- Lot #: 1276119, Exp 1/31/2029.
- Distribution
- U.S.A. Nationwide
- Quantity
- —
- Recall started
- May 28, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0563-2026
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Class II Ongoing
Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count bottle, DISTRIBUTED BY CASEY'S MARKETING COMPANY, ANKENY, IA 50521, UPC: 0 98437 24361 9.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Lots, distribution and details
- Lots / codes
- Lot #: 1276118, Exp 1/31/2029.
- Distribution
- U.S.A. Nationwide
- Quantity
- —
- Recall started
- May 28, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0562-2026
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Class II Ongoing
Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 chewable tablets, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-595-23.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Lots, distribution and details
- Lots / codes
- Lot #: 1716089, Exp 1/31/2029.
- Distribution
- U.S.A. Nationwide
- Quantity
- —
- Recall started
- May 28, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0561-2026
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Class II Ongoing
Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chewable, 96-count bottle, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-106-80.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Lots, distribution and details
- Lots / codes
- Lot #: 1276118, Exp 1/31/2029.
- Distribution
- U.S.A. Nationwide
- Quantity
- —
- Recall started
- May 28, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0560-2026
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Class II Ongoing
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle, Haleon, Warren, NJ 07059, UPC 3 0766 3072 10 9.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Lots, distribution and details
- Product
- HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle, Haleon, Warren, NJ 07059, UPC 3 0766 3072 10 9.
- Lots / codes
- Lot #: 1076169, Exp 2/28/2029.
- Distribution
- U.S.A. Nationwide
- Quantity
- —
- Recall started
- May 28, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0559-2026
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Class II Ongoing
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Lots, distribution and details
- Lots / codes
- Lot #: 1096075, 1096076, 1096077, 1096078, Exp 1/31/2029.
- Distribution
- U.S.A. Nationwide
- Quantity
- —
- Recall started
- May 28, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0558-2026
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Class II Ongoing
KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRUG COMPANY, INC., 2 CHARLES COURT/DAYTON, NJ 08810, FOR: Costco Wholesale Corporation, 999 Lake Drive,…
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Lots, distribution and details
- Product
- KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRUG COMPANY, INC., 2 CHARLES COURT/DAYTON, NJ 08810, FOR: Costco Wholesale Corporation, 999 Lake Drive, Issaquah, WA 98027, NDC 63981-171-80
- Lots / codes
- Lot#: 1716059, 1716060, 1716061, 1716062, 1716063, 1716218, 1716219, 1716228, 1716229, 1716238, Exp 2/28/2029; 1716258, Exp 3/31/2029.
- Distribution
- U.S.A. Nationwide
- Quantity
- —
- Recall started
- May 28, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0557-2026
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Class II Ongoing
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.
Reason: Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Lots, distribution and details
- Lots / codes
- Lot: 24123460, Expires: October 31, 2027.
- Distribution
- U.S.A. Nationwide
- Quantity
- 15,696 x 30's bottles
- Recall started
- May 5, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0556-2026
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Class II Ongoing
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
Reason: CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Lots, distribution and details
- Lots / codes
- Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
- Distribution
- US Nationwide.
- Quantity
- 50 bottles
- Recall started
- May 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0555-2026
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Class II Ongoing
Lidocaine HCl Injection USP, 25×5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.
- Distribution
- USA Nationwide
- Quantity
- 210625 ampules
- Recall started
- May 12, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0554-2026
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Class III Ongoing
Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02
Reason: Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Lots, distribution and details
- Product
- Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02
- Lots / codes
- Lot, expiry: Lot 3LC26029A, exp Feb-2029; Lot 3LC26031A, exp Mar-2029
- Distribution
- US Nationwide.
- Quantity
- 168,300 vials
- Recall started
- May 18, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0552-2026
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Class III Ongoing
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.
Reason: Failed Stability Specifications
Lots, distribution and details
- Lots / codes
- Lot # 402805, 407596, Exp Date: 08/2026.
- Distribution
- US Nationwide.
- Quantity
- 2,736 bottles
- Recall started
- May 18, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0551-2026
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Class III Ongoing
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.
Reason: Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Lots, distribution and details
- Lots / codes
- Lot #: 56841, Expires: 03/2028
- Distribution
- Nationwide within the U.S
- Quantity
- 59,808 pouches (4,272 Individual Folding Carton (IFC))
- Recall started
- May 14, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0550-2026
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Class I Ongoing
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037.
Reason: Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Lots, distribution and details
- Lots / codes
- Lot #: 1024088, Exp 11/30/2026
- Distribution
- USA Nationwide and Bahamas
- Quantity
- 690 tubes
- Recall started
- April 24, 2026 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0553-2026
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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
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.
Reason: Subpotent Drug
Lots, distribution and details
- Product
- fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.
- Lots / codes
- Lot#: 20260310FEN-1, Exp. Date: 09/06/2026
- Distribution
- Nationwide.
- Quantity
- 376 cassettes
- Recall started
- May 12, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0548-2026
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Class II Ongoing
cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 cartons, STARTER KIT,…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 cartons, STARTER KIT, NDC 50474-710-81.
- Lots / codes
- Lot: CVZFW, Exp.:2026-JUL-04; CVZYG, Exp.: 2026-AUG-19; CWSYT, Exp.: 2026-OCT-22; CWDZY, Exp.:2026-NOV-20; CWTSD, Exp.:2026-DEC-11; CVTFK, Exp.:2026-JUL-04; CVTSN, Exp.: 2026-AUG-19; CWVGP. Exp.:2026-DEC-11; CVWXT, CVWXV, CVWXW, Exp.:2026-JUL-04; CWHFF, Exp.: 2026-OCT-22; CWNDS, Exp.: 2026-DEC-11.
- Distribution
- US Nationwide.
- Quantity
- 141,708 cartons
- Recall started
- May 8, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0546-2026
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Class II Ongoing
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3).
Reason: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Lots, distribution and details
- Lots / codes
- Lots: a) M411147, Expires: 08/2026; M502100, M502099, Expires: 01/2027.
- Distribution
- Nationwide within the U.S
- Quantity
- 10,992 bottles
- Recall started
- April 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0545-2026
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Class II Ongoing
Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (…
Reason: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Lots, distribution and details
- Product
- Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1).
- Lots / codes
- Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 23,880 bottles
- Recall started
- April 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0544-2026
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Class II Ongoing
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
Reason: Defective Container; packets were found to be either empty or partially full.
Lots, distribution and details
- Product
- Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
- Lots / codes
- Lot M251109, exp Nov 2027
- Distribution
- Nationwide in the USA
- Quantity
- 3964 Cartons
- Recall started
- May 12, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0543-2026
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.