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.
183 recalls
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Class III Ongoing
Total Parental Nutrition – Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Inc., A…
Reason: Incorrect Product Formulation
Lots, distribution and details
- Product
- Total Parental Nutrition – Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Inc., Atlanta, 1750 Corp Dr. Ste 725, Norcross, GA 30093 (844) 903-6418
- Lots / codes
- Lot #: 20-1535990-0-1 & 20-1535892-0-1, Exp. Date 16 July 2026
- Distribution
- GA only
- Quantity
- (2) patient-specific TPN prescriptions
- Recall started
- July 16, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0740-2026
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Class II Ongoing
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99
Reason: shortfill; reports of empty capsules.
Lots, distribution and details
- Lots / codes
- Batch # DMC125018A, Exp Date: 07/2027.
- Distribution
- US Nationwide.
- Quantity
- 6,408 bottles distributed to market
- Recall started
- July 23, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0733-2026
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Class III Ongoing
Dabigatran Etexilate Capsules, 75 mg, 30-count (3×10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 4…
Reason: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Lots, distribution and details
- Product
- Dabigatran Etexilate Capsules, 75 mg, 30-count (3×10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.
- Lots / codes
- Lot: 25141586, Exp. April 30, 2027.
- Distribution
- USA Nationwide
- Quantity
- 936 cartons x 12 x 3 x 10 (in blister pack)
- Recall started
- July 16, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0739-2026
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Class III Ongoing
Dabigatran Etexilate Capsules, 75 mg, 60-count (6×10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46…
Reason: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Lots, distribution and details
- Product
- Dabigatran Etexilate Capsules, 75 mg, 60-count (6×10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.
- Lots / codes
- Lot: 25141585, Exp. April 30, 2027.
- Distribution
- USA Nationwide
- Quantity
- 924 cartons x 12 x 6 x 10 (in blister pack)
- Recall started
- July 16, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0738-2026
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Class III Ongoing
Dabigatran Etexilate Capsules, 150 mg, 60-count (6×10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN…
Reason: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Lots, distribution and details
- Product
- Dabigatran Etexilate Capsules, 150 mg, 60-count (6×10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.
- Lots / codes
- Lot: 25141583, Exp. April 30, 2027.
- Distribution
- USA Nationwide
- Quantity
- 3,600 cartons x 6 x 10 (in blister pack)
- Recall started
- July 16, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0737-2026
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Class II Ongoing
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00 (vial label) & ND…
Reason: Presence of precipitate
Lots, distribution and details
- Product
- Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00 (vial label) & NDC 67457-386-81 (carton label).
- Lots / codes
- Lot #: 3241653, Exp 4/30/2027
- Distribution
- USA Nationwide
- Quantity
- 5688 vials
- Recall started
- July 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0734-2026
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Class II Ongoing
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.
Reason: CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Lots, distribution and details
- Lots / codes
- Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.
- Distribution
- Nationwide within the United States.
- Quantity
- N/A
- Recall started
- July 23, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0731-2026
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Class II Ongoing
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL – bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26.
Reason: Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Lots, distribution and details
- Lots / codes
- Lot # DLHU0031, Exp Date: 06/30/2027.
- Distribution
- Nationwide in the USA.
- Quantity
- N/A
- Recall started
- July 22, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0730-2026
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 2, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.