Drug recalls, 2026-W25

FDA drug recalls, June 15 to 21, 2026

FDA posted 11 drug recalls the week of June 15, 2026: 3 Class I, 6 Class II, and 2 Class III. Breckenridge Pharmaceutical, Inc. and SUN PHARMACEUTICAL INDUSTRIES INC have the most, with 2 each.

License: openFDA publishes this file under CC0 1.0.

FDA sorts recalls by risk. Class I: using the product could cause serious health problems or death. Class II: it could cause temporary or reversible health problems. Class III: it is unlikely to cause health problems.

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Recalls posted June 15 to 21, 2026

Class I · Posted June 17, 2026 · Started June 4, 2026 · Ongoing

Gas-X Extra Strength

Product: Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.
Firm: Haleon US Holdings LLC, Warren, NJ
Reason: Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Lots: Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.
Quantity: 35,883 boxes/carton
Distribution: Nationwide within the United States
RxNorm: Not matched to RxNorm in the FDA record
Recall number: D-0595-2026

Class II · Posted June 17, 2026 · Started June 4, 2026 · Ongoing

duloxetine hydrochloride

Product: Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Firm: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lots: Lot: a) 241074C, Exp. Date May 2027; 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, Exp. Date February 2027; 240316,Exp. Date January 2027; 232311, Exp. Date November 2026; b) 240978C, 241052C, Exp. Date April 2027.
Quantity: 359,676 bottles
Distribution: Nationwide within the United States
RxNorm: duloxetine hydrochloride (RxCUI 596926, 596930, 596934, 616402)
Recall number: D-0583-2026

Class II · Posted June 17, 2026 · Started June 4, 2026 · Ongoing

duloxetine hydrochloride

Product: Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
Firm: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lots: Lot: 241180C, Exp. Date April 2027.
Quantity: 14,729 bottles.
Distribution: Nationwide within the United States
RxNorm: duloxetine hydrochloride (RxCUI 596926, 596930, 596934, 616402)
Recall number: D-0582-2026

Class III · Posted June 17, 2026 · Started June 3, 2026 · Ongoing

primidone

Product: Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
Firm: Amneal Pharmaceuticals, LLC, Bridgewater, NJ
Reason: Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Lots: Lot AM251676, EXP 11/31/2028
Quantity: 27,936 100-count bottles
Distribution: Nationwide within the USA.
RxNorm: primidone (RxCUI 96304, 198150)
Recall number: D-0585-2026

Class I · Posted June 17, 2026 · Started June 1, 2026 · Ongoing

BEEKEEPER'S NATURALS Saline Nasal Spray

Product: BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789.
Firm: BEEKEEPER'S NATURALS USA INC., Covina, CA
Reason: Microbial Contamination of Non-Sterile Products
Lots: Lot #: 5950, Exp. Date 02/2028
Quantity: 1680 bottles
Distribution: Nationwide within the United States.
RxNorm: Not matched to RxNorm in the FDA record
Recall number: D-0620-2026

Class II · Posted June 17, 2026 · Started June 1, 2026 · Ongoing

minocycline hydrochloride

Product: Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30
Firm: Ascend Laboratories, LLC, Bedminster, NJ
Reason: Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Lots: Lot# 25141635, Exp 4/30/2028
Quantity: 360 30-count bottles
Distribution: Nationwide in the USA
RxNorm: minocycline hydrochloride (RxCUI 629695, 629697, 629699, 858062, 858372, +3 more)
Recall number: D-0597-2026

Class II · Posted June 17, 2026 · Started May 29, 2026 · Ongoing

budesonide

Product: Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49.
Firm: SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
Reason: Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Lots: Lot #: BAG0074A, Exp. Date: 1/31/2027.
Distribution: Nationwide within the United States
RxNorm: budesonide (RxCUI 252559, 349094, 351109)
Recall number: D-0607-2026

Class II · Posted June 17, 2026 · Started May 29, 2026 · Ongoing

niacin

Product: GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, Camarillo, CA 93012. NDC 51407-268-90.
Firm: Golden State Medical Supply Inc., Camarillo, CA
Reason: Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Lots: Lots: GS065128, GS065844, GS066695, GS067432, GS067993, expires: 01/31/2027.
Quantity: 2,961 bottles
Distribution: Within the U.S Market.
RxNorm: niacin (RxCUI 1098134, 1098141)
Recall number: D-0587-2026

Class II · Posted June 17, 2026 · Started May 22, 2026 · Ongoing

ethanol

Product: Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85.
Firm: Zep Inc, Emerson, GA
Reason: Microbial contamination of sterile products
Lots: Batch # E2612116, Exp Date: April 2029.
Quantity: 5 drums
Distribution: US Nationwide.
RxNorm: ethanol (RxCUI 1041849)
Recall number: D-0586-2026

Class III · Posted June 17, 2026 · Started May 14, 2026 · Ongoing

epinephrine

Product: Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
Firm: Fresenius Kabi USA, LLC, Lake Zurich, IL
Reason: Failed Impurities/Degradations Specifications
Lots: Batch # 6133313, 6133314, Exp Date: 06/2026; Batch # 6133315, Exp Date: 07/2026; Batch # 6133682, Exp Date: 09/2026; Batch # 6134812, 6134813, Exp Date: 04/2027.
Quantity: 898,050 vials
Distribution: US Nationwide.
RxNorm: epinephrine (RxCUI 1660014)
Recall number: D-0581-2026

Class I · Posted June 17, 2026 · Started May 12, 2026 · Ongoing

doxorubicin hydrochloride

Product: DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01.
Firm: SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
Reason: Presence of Particulate matter: Particulate matter identified as glass.
Lots: Lot HAG2581B, expires: 05/31/2027
Quantity: 675 vials
Distribution: U.S. Nationwide
RxNorm: doxorubicin hydrochloride (RxCUI 1790115, 1790127)
Recall number: D-0580-2026

Source: openFDA drug enforcement reports, as of October 14, 2026. Publisher page

About this data

Each row is one FDA drug enforcement report: one product from one firm. A week here is Monday to Sunday, keyed on the date FDA listed the recall in its weekly Enforcement Report. The date the firm started the recall is shown on each row and is often weeks earlier.

Class I means use of the product could cause serious health problems or death. Class II means it could cause temporary or reversible health problems. Class III means it is unlikely to cause health problems. RxNorm names and RxCUIs come from openFDA's match of the product to its drug label. Compounded products often have no match.

This page lists public records. It is not medical advice. Check the FDA record before acting on a recall.

Source: openFDA drug enforcement reports, as of October 14, 2026. Publisher page

Get this every Monday

Recalls posted June 15 to 21, 2026

Gas-X Extra Strength

duloxetine hydrochloride

duloxetine hydrochloride

primidone

BEEKEEPER'S NATURALS Saline Nasal Spray

minocycline hydrochloride

budesonide

niacin

ethanol

epinephrine

doxorubicin hydrochloride

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