Drug recalls, 2025-W46

FDA drug recalls, November 10 to 16, 2025

FDA posted 5 drug recalls the week of November 10, 2025: 5 Class II. Zydus Pharmaceuticals (USA) Inc has the most, with 3.

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 November 10 to 16, 2025

Class II · Posted November 12, 2025 · Started October 22, 2025 · Ongoing

clomipramine hydrochloride

Product
clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India.
Firm
Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Reason
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Lots
a) Lot # E403069, Exp Date: 04/2026; Lot # E406504, Exp Date: 07/2026; Lot # E309177, Exp Date: 11/2025; Lot # E400262, Exp Date: 12/2025; Lot # E404200, Exp Date: 05/2026 b) Lot # E403070, Exp Date: 04/2026; Lot # E406505, Exp Date: 07/2026; Lot # E407631, Exp Date: 08/2026; Lot # E400263, Exp Date: 12/2025; Lot # E404202, Exp Date: 05/2026 c) Lot # E403071, Exp Date: 04/2026; Lot # E407632, Exp Date: 08/2026; Lot # E405848, E405284, Exp Date: 07/2026; Lot # E400264, Exp Date: 12/2025; Lot # E404201, Exp Date: 05/2026
Distribution
Nationwide in the US
RxNorm
clomipramine hydrochloride (RxCUI 857297, 857301, 857305)
Recall number
D-0154-2026

Class II · Posted November 12, 2025 · Started October 22, 2025 · Ongoing

clomipramine hydrochloride

Product
clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
Firm
Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Reason
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Lots
a) Lot # E410157, Exp Date: 12/2026; Lot # E407176, Exp Date: 08/2026; Lot # E405845, Exp Date: 06/2026; Lot # E400943, Exp Date: 01/2026 b)Lot # E410156, Exp Date: 12/2026; Lot # E400942, Exp Date: 01/2026 c) Lot # E410158, Exp Date: 12/2026; Lot # E407128, Exp Date: 08/2026; Lot # E405846, Exp Date: 06/2026; Lot # E400944, Exp Date: 01/2026
Distribution
Nationwide in the US
RxNorm
clomipramine hydrochloride (RxCUI 857297, 857301, 857305)
Recall number
D-0153-2026

Class II · Posted November 12, 2025 · Started October 22, 2025 · Ongoing

clomipramine hydrochloride

Product
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
Firm
Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Reason
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Lots
a) Lot # E408871, Exp Date: 10/2026; Lot # E405282, Exp Date: 06/2026; Lot # E400386, Exp Date: 12/2025 b) Lot # E408872, Exp Date: 10/2026; Lot # E405280, Exp Date: 06/2026 c) Lot # E408873, Exp Date: 10/2026; Lot # E405281, Exp Date: 06/2026; Lot # E400387, Exp Date: 12/2025
Distribution
Nationwide in the US
RxNorm
clomipramine hydrochloride (RxCUI 857297, 857301, 857305)
Recall number
D-0152-2026

Class II · Posted November 12, 2025 · Started October 17, 2025 · Ongoing

pain reliever

Product
Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01
Firm
Aero Healthcare, Valley Cottage, NY
Reason
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Lots
Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01
Distribution
US Nationwide.
RxNorm
pain reliever (RxCUI 702316)
Recall number
D-0155-2026

Class II · Posted November 12, 2025 · Started October 13, 2025 · Ongoing

Amoxicillin and Clavulanate Potassium for Oral Suspension USP

Product
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7.
Firm
Teva Pharmaceuticals USA, Inc, Parsippany, NJ
Reason
Subpotent drug; Clavulanate Potassium component
Lots
Lot # 100062316, Exp Date: 01/2026
Quantity
4680 cartons
Distribution
Distributed in three (3) States: MS, OH, CA.
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0151-2026

Source: openFDA drug enforcement reports, as of October 21, 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 21, 2026. Publisher page

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