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.

126–150 of 405

  • LowFDA (Drugs)·D-0342-2019·2018-12-26

    CBI Laboratories Recalls Subpotent Options Rx Sunscreen Tubes

    CBI Laboratories is recalling 2,055 tubes of Options Rx Anti-Oxidant Oil-Free Sunscreen because the product failed to meet specifications for active ingredient percentages.

    Product
    Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For Credentials Skincare Fort Worth, TX 76155
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0130-2019·2018-10-31

    RXQ Compounding Recalls Subpotent Lidocaine and Epinephrine Injection Vials

    RXQ Compounding LLC is recalling 395 vials of Lidocaine 1% + Epinephrine 1:100,000 injection solution because testing revealed the product was subpotent.

    Product
    Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC 7073197450
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0072-2019·2018-10-24

    Mushatt's No. 9 PsoriWash Medicated Wash Recalled for Microbial Contamination

    Product Quest Manufacturing LLC is recalling Mushatt's No. 9 PsoriWash Medicated Wash due to microbial contamination and low salicylic acid levels.

    Product
    Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g) tube, Distributed by Mushatts, LLC, P.O. Box 372476, Satellite Beach, FL 32937, UPC 8 58245 00203 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0067-2019·2018-10-24

    Rite Aid First Aid Antibiotic Ointment Recalled for Low Bacitracin Zinc

    Product Quest Manufacturing LLC is recalling Rite Aid First Aid Antibiotic Ointment because the bacitracin zinc ingredient was found to be subpotent.

    Product
    Rite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units, bacitracin zinc 400 units per gram), 2 OZ (56 g) tube, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 55441 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0073-2019·2018-10-24

    CVS Triple Antibiotic Ointment Spray Recalled for Low Bacitracin Zinc Levels

    Product Quest Manufacturing LLC is recalling CVS Health Triple Antibiotic Ointment Spray because the bacitracin zinc ingredient was found to be subpotent.

    Product
    CVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400 units, neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units per gram), 2 OZ (57 g) can, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Product#957603, UPC 0 50428 29
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0070-2019·2018-10-24

    Cicatricure Scar Cream Recalled for Low Active Ingredient Levels

    Product Quest Manufacturing LLC is recalling Cicatricure Scar Cream + Sunscreen SPF 30 because the octocrylene and avobenzone levels were found to be lower than required.

    Product
    Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distributed by: Genomma Lab USA Inc., Houston, TX 77027, UPC 6 50067 00018 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0069-2019·2018-10-24

    Well at Walgreens Scar Cream Recalled for Low Active Ingredient Levels

    Product Quest Manufacturing LLC is recalling 6,516 tubes of Well at Walgreens Scar Cream with SPF 30 because the octocrylene and avobenzone levels were found to be lower than required.

    Product
    Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0012-2019·2018-10-17

    InvaGen Recalls Amlodipine Besylate Tablets Due to Subpotency

    InvaGen Pharmaceuticals is recalling one lot of Amlodipine Besylate 10 mg tablets because the product failed to meet assay specifications at 3-month stability conditions.

    Product
    AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0003-2019·2018-09-26

    QuVa Pharma Recalls Subpotent Norepinephrine IV Bags Nationwide

    QuVa Pharma is recalling 528 bags of Norepinephrine 4 mg in 5% Dextrose because the active ingredient may be missing. The product was distributed to hospitals nationwide.

    Product
    Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1076-2018·2018-08-22

    Acne Treatment Pads Recalled for Subpotent Salicylic Acid Levels

    Huijing (Shanghai) Bio-tech Co., Ltd. is recalling Acne Treatment Pads because the active ingredient level does not match the label.

    Product
    Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Distributed by: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320, NDC 71537-001-02
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0927-2018·2018-07-18

    Lupin Recalls Nitrofurantoin Oral Suspension Due to Subpotent Drug

    Lupin Pharmaceuticals is recalling Nitrofurantoin Oral Suspension because the drug is subpotent and failed content uniformity testing.

    Product
    NITROFURANTOIN — NITROFURANTOIN (NITROFURANTOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0918-2018·2018-07-18

    SCA Pharmaceuticals Recalls Subpotent Buffered Lidocaine Injection

    SCA Pharmaceuticals is recalling 3,984 syringes of Buffered Lidocaine 1% Injection because stability data does not support the current expiration dating.

    Product
    Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0978-2018·2018-07-18

    Mylan Recalls Subpotent Triamterene and Hydrochlorothiazide Tablets Nationwide

    Mylan Pharmaceuticals is voluntarily recalling 28,436 bottles of Triamterene and Hydrochlorothiazide Tablets because the medication was found to be subpotent.

    Product
    Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0889-2018·2018-07-04

    Advanced Pharma Recalls Subpotent Fentanyl Citrate Prefilled Syringes

    Advanced Pharma Inc. is recalling 100 prefilled syringes of fentanyl citrate because the final drug concentration is subpotent compared to the label.

    Product
    fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0839-2018·2018-05-23

    Apotex Recalls Subpotent Piperacillin and Tazobactam Injection Vials

    Apotex Inc. is recalling 121,693 vials of Piperacillin and Tazobactam for Injection due to high impurity levels that decreased the drug's potency.

    Product
    Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0840-2018·2018-05-23

    Apotex Recalls Subpotent Piperacillin and Tazobactam Injection Vials

    Apotex Inc. is recalling specific lots of Piperacillin and Tazobactam for Injection due to high impurity levels that decreased the drug's potency.

    Product
    Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0713-2018·2018-05-02

    Lyne Laboratories Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Lyne Laboratories is recalling 23,453 units of Fluocinolone Acetonide Topical Oil because the product is subpotent. The recall is voluntary and classified as FDA Class II.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0712-2018·2018-05-02

    Lyne Laboratories Recalls Subpotent Fluocinolone Acetonide Ear Drops

    Lyne Laboratories is recalling 17,939 units of Fluocinolone Acetonide Topical Oil ear drops because the medication is subpotent.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0711-2018·2018-05-02

    Lyne Laboratories Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Lyne Laboratories is recalling 12,572 units of Fluocinolone Acetonide Topical Oil because the product is subpotent. The recall is voluntary and was initiated by the firm.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0683-2018·2018-04-25

    Leadiant Recalls Subpotent Cystaran Ophthalmic Solution

    Leadiant Biosciences is recalling 3,398 bottles of Cystaran ophthalmic solution because the active ingredient was below the required specification.

    Product
    CYSTARAN — CYSTARAN (CYSTEAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0612-2018·2018-04-04

    Akorn Recalls 24-Hour Oral Care Kits Due to Low Chlorhexidine Levels

    Akorn, Inc. is recalling 24-Hour Oral Care q2 Kits because the chlorhexidine gluconate oral rinse contained in some units had low potency levels.

    Product
    24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, In
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0611-2018·2018-04-04

    Akorn Recalls Subpotent Chlorhexidine Gluconate Oral Rinse Unit Dose Cups

    Akorn, Inc. is recalling Chlorhexidine Gluconate Oral Rinse unit dose cups due to product crystallization and low assay results.

    Product
    Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0613-2018·2018-04-04

    Akorn Recalls Subpotent Chlorhexidine Oral Rinse Kits

    Akorn, Inc. is recalling 24-HOUR Oral Care q4 Kits containing subpotent Chlorhexidine Gluconate Oral Rinse due to product crystallization.

    Product
    24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, In
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0589-2018·2018-03-21

    Psoriasin Daytime Relief Cream Recalled for Subpotent Coal Tar Content

    Alva-Amco Pharmacal Companies is recalling Psoriasin Daytime Relief Cream because it failed to maintain its label claim of coal tar throughout its expiry period.

    Product
    Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharmacal Cos., Inc., Niles, IL 60714, USA. NDC 52389-745-56, UPC 0 72959 01045 4.
    Category
    Drug
    Distribution
    Distributed nationwide