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 II Ongoing
EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68.
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-0577-2026
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Class II Ongoing
EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Lots, distribution and details
- Lots / codes
- Lot #: 1276118, 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-0576-2026
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Class II Ongoing
GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-171-68.
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-0575-2026
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Class II Ongoing
GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-129-22.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Lots, distribution and details
- Lots / codes
- Lot #: 1276118, 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-0574-2026
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Class II Ongoing
HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5.
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-0572-2026
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Class II Ongoing
HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82497 1.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Lots, distribution and details
- Lots / codes
- Lot #: 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-0571-2026
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Class II Ongoing
Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, Distributed by: Harris Teeter, LLC.,MATTHEWS, NC 28105, UPC: 0 72036-73108-1.
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-0570-2026
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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., UP: 0 32251-92282-4.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Lots, distribution and details
- Lots / codes
- Lot #: 1716259, expires: MAR 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-0569-2026
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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
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
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
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 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
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Class II Ongoing
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Reason: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Lots, distribution and details
- Lots / codes
- Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.
- Distribution
- U.S. Nationwide.
- Quantity
- 285,330 blister cards
- Recall started
- May 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0542-2026
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Class III Ongoing
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Lots, distribution and details
- Product
- Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
- Lots / codes
- Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
- Distribution
- USA Nationwide
- Quantity
- 225,000 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-0537-2026
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.