The Recall Desk

Hazard

Subpotency recalls

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

What the numbers show

Total
173
Critical
0
Severe
15
Most recent
2026-07-22

Of the 173 subpotency recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 15 (9%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all subpotency 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.

151–173 of 173

  • SevereFDA (Drugs)·D-0093-2017·2016-10-19

    Pharmedium Recalls Subpotent Fentanyl Citrate Syringes Nationwide

    Pharmedium Services, LLC is recalling 500 syringes of fentanyl citrate due to confirmed subpotency. The product was distributed nationwide.

    Product
    fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0049-2017·2016-10-19

    Pharmedium Recalls Heparin Sodium Syringes Due to Subpotency and Stability Concerns

    Pharmedium Services, LLC is recalling 350 syringes of Heparin Sodium Injection USP because confirmed subpotency and stability data do not support the expiry date.

    Product
    HEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 Heparin USP Units per mL, Rx only, PharMEDium, Product code 2K1926.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0034-2017·2016-10-19

    Pharmedium Recalls Fentanyl Citrate Injection Due to Subpotency and Stability Issues

    Pharmedium Services, LLC is recalling specific lots of fentanyl citrate injection because confirmed subpotency and stability data do not support the expiry date.

    Product
    fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1062-2016·2016-07-13

    Lyne Laboratories Recalls Cyproheptadine Hydrochloride Syrup Due to Subpotency

    Lyne Laboratories is recalling specific lots of Cyproheptadine Hydrochloride Syrup because the product was found to be subpotent. The recall affects 12,215 bottles distributed in New Jersey.

    Product
    Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant screw closure, Rx only, Distributed by: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Manufactured by: Lyne Laboratories, Inc., Brockton
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0855-2016·2016-05-25

    Renovo Patch Recalled for Lack of Approval and Subpotency

    TMIG Inc is recalling Renovo Patch because it was marketed without FDA approval and three lots were found to be subpotent.

    Product
    Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1085-2015·2015-06-03

    Boehringer Ingelheim Roxane Recalls Subpotent Acarbose Tablets

    Boehringer Ingelheim Roxane Inc is recalling Acarbose 50 mg tablets because potency was below specification at a 9-month stability time point.

    Product
    ACARBOSE — ACARBOSE (ACARBOSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0413-2015·2015-03-25

    Mylan Recalls Subpotent Nicardipine Hydrochloride Injection Vials

    Mylan Institutional LLC is recalling specific lots of Nicardipine Hydrochloride Injection because the product failed potency and impurity specifications.

    Product
    Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0172-2015·2014-11-05

    West-Ward Recalls Ethambutol Hydrochloride Tablets Due to Stability Failure

    West-Ward Pharmaceutical Corp. is recalling 5,596 bottles of Ethambutol Hydrochloride Tablets, USP, 100 mg, due to an out-of-specification stability result.

    Product
    VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for VersaPharm Incorporated Marietta, GA 30065-1509 Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 61748-011-01
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0043-2015·2014-10-29

    American Health Packaging Recalls Subpotent Methylprednisolone Tablets

    American Health Packaging is recalling 2,005 cartons of Methylprednisolone 4 mg tablets because they failed to meet potency standards at a 6-month stability time point.

    Product
    METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1241-2014·2014-04-30

    GlaxoSmithKline Recalls Nicorette Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling specific lots of Nicorette 2 mg lozenges because they failed quality specifications, including being overly thick, soft, and sub or superpotent.

    Product
    NICORETTE — NICORETTE (NICOTINE POLACRILEX)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1148-2014·2014-03-12

    Fresenius Kabi Recalls Heparin Sodium Injection Due to Subpotency

    Fresenius Kabi is recalling Heparin Sodium Injection vials because they may contain less active ingredient than labeled.

    Product
    HEPARIN SODIUM — HEPARIN SODIUM (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1088-2014·2014-03-05

    Actavis Recalls Subpotent Gelnique Oxybutynin Chloride Gel Samples

    Actavis is recalling Gelnique (oxybutynin chloride) Gel 10% physician samples because drug potency was compromised during shipment.

    Product
    Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven heat-sealed sachets. Rx Only. Watson Pharmaceuticals Inc, Corona, CA, 92890. NDC: 52544-084-77.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-428-2013·2013-05-29

    Levoxyl Tablets Recalled for Low Potency at Expiry

    King Legacy is recalling Levoxyl tablets because they were below specification for potency at the expiry stability point.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-422-2013·2013-05-29

    Levoxyl Tablets Recalled for Low Potency at Expiry

    King Legacy is recalling Levoxyl tablets because they were below specification for potency at the expiry stability point.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-427-2013·2013-05-29

    Levoxyl tablets recalled for subpotent levothyroxine sodium

    King Legacy is recalling Levoxyl tablets because they were below specification for potency at the expiry stability point.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-421-2013·2013-05-29

    King Legacy Recalls Subpotent Levoxyl Levothyroxine Sodium Tablets

    King Legacy is recalling Levoxyl (levothyroxine sodium) tablets because they were below specification for potency at the expiry stability point.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-426-2013·2013-05-29

    Levoxyl Levothyroxine Sodium Tablets Recalled for Subpotency

    King Legacy is recalling Levoxyl tablets because they were below specification for potency at the expiry stability point.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1338-2013·2013-05-01

    Nexgen Pharma Recalls L-Arginine Supplement Due to Subpotency

    Nexgen Pharma is recalling a specific lot of L-Arginine L-Ornithine Alpha Lipoic Acid capsules because the Alpha Lipoic Acid ingredient is subpotent.

    Product
    Free Form Amino Acids L-Arginine 7 L-Ornithine Complex With Alpha-Lipoic Acid, Promotes Circulation and Muscle Development, Dietary Supplement, 50 Vegetarian Capsules, Gluten Free, Serving Size 2 Capsules. Each product is produced for a specific customer with their distribution
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-217-2013·2013-04-03

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling 8,736 bottles of Derma-Smoothe/FS topical oil because the product was found to be subpotent at the 12-month stability timepoint.

    Product
    Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-214-2013·2013-03-27

    Physicians Total Care Recalls Subpotent Levothyroxine Tablets

    Physicians Total Care is recalling Levothyroxine Tablets, USP, 0.175 mg, due to subpotency and stability issues. The recall affects specific lots distributed in Ohio and Georgia.

    Product
    Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles, Rx, Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK --- NDC 54868-4507-00
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-102-2013·2013-01-02

    Lloyd Inc. Recalls Subpotent Thyro-Tab 0.075 mg. Tablets

    Lloyd Inc. of Iowa is recalling 1.9 million Thyro-Tab 0.075 mg. tablets due to subpotency and stability issues.

    Product
    Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1673-2012·2012-09-12

    Medtech Recalls Little Remedies For Tummys Laxative Drops for Subpotency

    Medtech Products Inc. is recalling Little Remedies For Tummys Stimulant Laxative Drops because the sennosides ingredient is subpotent.

    Product
    Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc., Irvington, NY 10533, UPC 7 56184 12071 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1661-2012·2012-09-05

    Apotex Recalls Subpotent Leflunomide Tablets Nationwide

    Apotex Corp. is recalling specific lots of Leflunomide 10 mg tablets because they did not meet potency specifications.

    Product
    LEFLUNOMIDE — LEFLUNOMIDE (LEFLUNOMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide