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.

351–375 of 405

  • ModerateFDA (Drugs)·D-1180-2014·2014-04-02

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling 7,676 bottles of Fluocinolone Acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.

    Product
    SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-506-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1178-2014·2014-04-02

    Hill Dermaceuticals Recalls Subpotent Dermotic Ear Drops

    Hill Dermaceuticals is recalling Dermotic ear drops because the active ingredient was found to be subpotent during routine testing.

    Product
    DERMOTIC — DERMOTIC (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1177-2014·2014-04-02

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Scalp Oil

    Hill Dermaceuticals is recalling 7,292 bottles of Derma-Smoothe/FS scalp oil because the active ingredient was found to be subpotent during routine testing.

    Product
    DERMA-SMOOTHE/FS — DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1173-2014·2014-04-02

    Hill Dermaceuticals Recalls Subpotent DermOtic Oil Ear Drops

    Hill Dermaceuticals is recalling DermOtic Oil ear drops because the active ingredient was found to be subpotent during routine testing.

    Product
    DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1174-2014·2014-04-02

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling 14,226 bottles of Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.

    Product
    Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1166-2014·2014-03-26

    Pfizer Recalls Advil PM Caplets Due to Low Diphenhydramine Levels

    Pfizer is recalling 70,704 bottles of Advil PM caplets nationwide because the diphenhydramine citrate content was found to be out of specification.

    Product
    ADVIL PM — ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1087-2014·2014-03-05

    Actavis Recalls Clonazepam Tablets Due to Subpotent Tablet Weight

    Actavis Elizabeth LLC is recalling 13,608 bottles of Clonazepam 2 mg tablets because routine testing found one tablet with weight below specification.

    Product
    Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-11 packaged in White/Round HDPE 75 CC with white/round plastic 33 mm CRC closure shipped in corrugated 75 cc carton (24 bottles/carton)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1084-2014·2014-02-19

    Mylan Recalls Subpotent Levothyroxine Sodium Tablets Due to Stability Testing Failures

    Mylan Pharmaceuticals is recalling specific lots of Levothyroxine Sodium Tablets because stability testing showed the drug was below specification.

    Product
    Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-343-2014·2013-12-18

    Oxcarbazepine Tablets Recalled for Potential Subpotency

    Boehringer Ingelheim Roxane Inc. is recalling Oxcarbazepine Tablets, 150 mg, due to out-of-specification assay results and potential lower weight tablets.

    Product
    Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-347-2014·2013-12-18

    Taro Recalls Subpotent Ciclopirox Shampoo 1% Prescription Bottles

    Taro Pharmaceuticals is recalling 850 bottles of Ciclopirox Shampoo 1% because the product is subpotent. The recall is voluntary and nationwide.

    Product
    CICLOPIROX — CICLOPIROX (CICLOPIROX)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-323-2014·2013-12-11

    American Health Packaging Recalls Subpotent Valacyclovir HCl Tablets

    American Health Packaging is recalling 1,536 cartons of Valacyclovir HCl 500 mg tablets because they contain less active ingredient than labeled.

    Product
    Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged and Distributed by: American Health Packaging, Columbus, OH NDC 68084-633-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-019-2014·2013-12-04

    Cetylite Recalls Cetacaine Topical Anesthetic Due to Low Tetracaine Levels

    Cetylite Industries is recalling Cetacaine Topical Anesthetic Liquid because the tetracaine ingredient is below specification limits at the 21-month stability test point.

    Product
    CETACAINE ANESTHETIC — CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-008-2014·2013-11-27

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling Derma-Smoothe/FS topical oil because routine testing found the active ingredient to be subpotent.

    Product
    Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-150-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-007-2014·2013-11-27

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling specific lots of Derma-Smoothe/FS topical oil because routine testing found the active ingredient to be subpotent.

    Product
    Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-149-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-923-2013·2013-09-04

    Novocol Recalls Subpotent Lidocaine and Epinephrine Dental Injection Lots

    Novocol is recalling two lots of Lidocaine 2% with Epinephrine 1:100,000 injection because the epinephrine component may be subpotent.

    Product
    LIDOCAINE — LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-886-2013·2013-08-21

    Sanofi Recalls Subpotent Rifadin Capsules Due to Low Fill

    Sanofi-Synthelabo is recalling 998 bottles of Rifadin (rifampin) capsules because some capsules contained less medication than labeled.

    Product
    Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-841-2013·2013-08-14

    Sanofi Recalls Subpotent Rifadin Rifampin Capsules Due to Low Fill Volume

    Sanofi US is recalling 2,462 bottles of Rifadin (Rifampin) 150 mg capsules because some capsules contain low fill volume, resulting in subpotent drug.

    Product
    Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 0068-0510-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-814-2013·2013-07-31

    LA MER Sunscreen Recalled for Potentially Reduced Sun Protection

    Max Huber Research Labs is recalling LA MER SPF 18 Fluid Tint because the active ingredient avobenzone may be subpotent, potentially reducing the product's effectiveness.

    Product
    LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade LIGHT 02, UPC 7 47930 00481 3, MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-823-2013·2013-07-31

    Watson Recalls Oxycodone and Acetaminophen Capsules Due to Low Potency

    Watson Laboratories is recalling two lots of Oxycodone and Acetaminophen Capsules because the oxycodone content was found to be below specification at expiry.

    Product
    Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA92880.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-804-2013·2013-07-24

    Fresenius Kabi Recalls Subpotent Oxytocin Injection Vials

    Fresenius Kabi is recalling 221,600 vials of Oxytocin Injection, USP, due to a subpotent drug issue identified during a 15-month stability test.

    Product
    Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-610-2013·2013-07-03

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling 8,808 bottles of Derma-Smoothe/FS topical oil because routine testing found the active ingredient to be subpotent.

    Product
    Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-424-2013·2013-05-29

    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
  • HighFDA (Drugs)·D-431-2013·2013-05-29

    Levoxyl Levothyroxine Sodium Tablets Recalled for Low Potency

    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-429-2013·2013-05-29

    Levoxyl Recall: Subpotent Levothyroxine Sodium Tablets

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

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-423-2013·2013-05-29

    Levoxyl tablets recalled for subpotent drug levels

    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