The Recall Desk

Hazard

Subpotent Drug recalls

405 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
405
Critical
19
Severe
137
Most recent
2026-09-02

Of the 405 subpotent drug recalls we have scored against our rubric, 19 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 137 (34%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all subpotent drug recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

101–125 of 405

  • SevereFDA (Drugs)·D-1053-2020·2020-04-01

    Thrive Pharmacy Recalls Subpotent Buprenorphine Troches in Florida

    Thrive Pharmacy is recalling 403 buprenorphine troches in Florida because they contain less active ingredient than labeled.

    Product
    Buprenorphine Watermelon 8 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1052-2020·2020-04-01

    Thrive Pharmacy Recalls Subpotent Buprenorphine Troches in Florida

    Thrive Pharmacy is voluntarily recalling 71 Buprenorphine troches in Florida because the medication was found to be subpotent.

    Product
    Buprexone Banana cream 6-0.6 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0839-2020·2020-02-19

    Akorn Recalls Subpotent Hydrocortisone and Acetic Acid Otic Solution

    Akorn Inc is recalling 16,078 bottles of Hydrocortisone and Acetic Acid Otic Solution due to low assay results for the hydrocortisone component.

    Product
    Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0838-2020·2020-02-12

    Macleods Pharma Recalls Subpotent Pioglitazone and Metformin Tablets

    Macleods Pharma USA is recalling two lots of Pioglitazone and Metformin Hydrochloride tablets because they tested below the required potency levels.

    Product
    PIOGLITAZONE AND METFORMIN HYDROCHLORIDE — PIOGLITAZONE AND METFORMIN HYDROCHLORIDE (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0824-2020·2020-02-05

    FDA Recalls Nystatin Oral Suspension for Subpotent Assay Levels

    Pharmaceutical Associates Inc. is recalling Nystatin Oral Suspension because it failed potency testing at 12 months. Patients should stop using the product and consult their healthcare provider.

    Product
    NYSTATIN — NYSTATIN (NYSTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0628-2020·2020-01-01

    Spectrum Laboratory Products Recalls Subpotent Estriol Micronized USP

    Spectrum Laboratory Products is recalling specific lots of Estriol Micronized USP because assay results did not meet specifications.

    Product
    Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum Chemical
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0625-2020·2020-01-01

    Pharmedium Recalls Subpotent Repinephrine Bitartrate Injection Bags

    Pharmedium Services LLC is voluntarily recalling 5,820 bags of subpotent repinephrine bitartrate injection. The FDA classified this as a Class III recall.

    Product
    NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0627-2020·2020-01-01

    Pharmedium Recalls Subpotent Repinephrine Bitartrate Injection Bags

    Pharmedium Services LLC is recalling 5,808 bags of Repinephrine Bitartrate Injection due to subpotent drug levels. The FDA classified this as a Class III recall.

    Product
    NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0626-2020·2020-01-01

    Pharmedium Recalls Subpotent Repinephrine Bitartrate Injection Bags Nationwide

    Pharmedium Services LLC is voluntarily recalling 864 bags of repinephrine bitartrate injection because the drug was subpotent. The recall covers nationwide distribution in the U.S.

    Product
    NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0324-2020·2019-11-20

    Sato Pharmaceutical Recalls Subpotent Wal-Dram 2 Meclizine Hydrochloride Tablets

    Sato Pharmaceutical Inc. is voluntarily recalling specific lots of Wal-Dram 2 Quick-Dissolving tablets because they contain less than the labeled amount of meclizine hydrochloride.

    Product
    WAL-DRAM 2 QUICK-DISSOLVING — WAL-DRAM 2 QUICK-DISSOLVING (MECLIZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0323-2020·2019-11-20

    CVS Motion Sickness Tablets Recalled for Subpotent Drug Levels

    Sato Pharmaceutical is recalling CVS Motion Sickness Fast Melting tablets because they may contain less than the labeled amount of meclizine hydrochloride.

    Product
    CVS MOTION SICKNESS FAST MELTING — CVS MOTION SICKNESS FAST MELTING (MECLIZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0322-2020·2019-11-20

    Sato Pharmaceutical Recalls Subpotent Zentrip Meclizine Hydrochloride Strips

    Sato Pharmaceutical Inc. is voluntarily recalling Zentrip (meclizine Hydrochloride) 25 mg strips because the medication is subpotent. The recall covers 21,864 units distributed nationwide.

    Product
    Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 49873-803-01. UPC 4987301603
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0325-2020·2019-11-20

    Sato Pharmaceutical Recalls Subpotent Motion Sickness Strips Nationwide

    Sato Pharmaceutical Inc. is recalling 39,504 units of Motion Sickness Strips because the medication may contain less than the labeled amount of meclizine hydrochloride.

    Product
    Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 69842-288-01. UPC 5042849946
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0303-2020·2019-11-13

    Sato Pharmaceutical Recalls Sankaijo Botanical Laxative Tablets

    Sato Pharmaceutical Inc. is recalling Sankaijo Botanical Laxative tablets because the sennosides content is lower than the labeled claim.

    Product
    SANKAIJO — SANKAIJO (DOCUSATE SODIUM, SENNOSIDES)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1579-2019·2019-08-07

    ImprimisRx Recalls Subpotent Timolol-Dorzolamide-Latanoprost Ophthalmic Drops

    ImprimisRx NJ is recalling 246 bottles of Timolol-Dorzolamide-Latanoprost ophthalmic drops because the medication was found to be subpotent.

    Product
    Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1578-2019·2019-08-07

    ImprimisRx Recalls Subpotent Timolol-Latanoprost Ophthalmic Drops Nationwide

    ImprimisRx NJ is voluntarily recalling 405 bottles of Timolol-Latanoprost P-F ophthalmic drops because the medication was found to be subpotent.

    Product
    Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1439-2019·2019-07-10

    Amneal Recalls Subpotent Esterified Estrogens and Methyltestosterone Tablets

    Amneal Pharmaceuticals is recalling specific lots of Esterified Estrogens & Methyltestosterone Tablets because they failed potency testing.

    Product
    Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-172-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1438-2019·2019-07-10

    Amneal Recalls Subpotent Esterified Estrogens and Methyltestosterone Tablets

    Amneal Pharmaceuticals is recalling specific lots of Esterified Estrogens & Methyltestosterone tablets due to out-of-specification assay results.

    Product
    Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1343-2019·2019-06-19

    B. Braun Recalls Heparin Sodium Bags Due to Low Potency

    B. Braun Medical Inc. is recalling 40,176 bags of Heparin Sodium in Dextrose because testing showed the drug had lower potency than required by USP specifications.

    Product
    HEPARIN SODIUM IN DEXTROSE — HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1205-2019·2019-04-24

    Teva Recalls Subpotent Amoxicillin Oral Suspension Bottles Nationwide

    Teva Pharmaceuticals is recalling specific lots of Amoxicillin Oral Suspension because assay results were below specification limits. The affected bottles were distributed nationwide and in Puerto Rico.

    Product
    Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wale
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1065-2019·2019-03-27

    Heritage Pharmaceuticals Recalls Subpotent Etomidate Injection Vials

    Heritage Pharmaceuticals is recalling 11,888 vials of Etomidate Injection because the drug was found to be subpotent. The recall is voluntary and nationwide.

    Product
    Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals Inc. Made in India, NDC 23155-160-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0374-2019·2019-01-16

    PharMEDium Recalls Subpotent Buffered Lidocaine HCl Syringes Nationwide

    PharMEDium Services is voluntarily recalling 7,711 syringes of 0.9% Buffered Lidocaine HCl because the product was found to be subpotent.

    Product
    0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land,
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0346-2019·2019-01-09

    Lupin Recalls Subpotent Nitrofurantoin Oral Suspension Lots

    Lupin Pharmaceuticals is recalling specific lots of Nitrofurantoin Oral Suspension because the drug was found to contain less active ingredient than required.

    Product
    NITROFURANTOIN — NITROFURANTOIN (NITROFURANTOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1207-2019·2018-12-26

    Sun Pharmaceutical Recalls Subpotent Absorica LD Isotretinoin Capsules

    Sun Pharmaceutical Industries is recalling Absorica LD (Isotretinoin) capsules because the active ingredient content was lower than the required specification limit.

    Product
    ABSORICA LD — ABSORICA LD (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide