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.

101–125 of 173

ModerateFDA (Drugs)·D-0454-2022·2022-02-02
CTx7 Kit Recalled for Subpotent Sodium Fluoride Content
The FDA is recalling CTx7 Kits distributed nationwide because the product contains less sodium fluoride than stated on the label.
Product
CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and one bottle of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0459-2022·2022-02-02
CariFree CTx4 Gel 5000 Subpotent Sodium Fluoride Recall
Dental Alliance Holdings LLC is recalling CariFree CTx4 Gel 5000 fluoride gel tubes because they contain less sodium fluoride than stated on the label. The affected product is CTx12 5000 Kit lot 142017.
Product
CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0456-2022·2022-02-02
CariFree CTx26 Kit Recalled for Subpotent Sodium Fluoride Content
Dental Alliance Holdings LLC is recalling the CTx26 Kit because it contains less sodium fluoride than listed on the product label. Affected consumers should contact their dentist or healthcare provider.
Product
CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and two bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle an two boxes of 4f
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0455-2022·2022-02-02
CTx21 Kit Dental Products Recalled for Subpotent Sodium Fluoride Content
Dental Alliance Holdings LLC is recalling the CTx21 Kit because the product contains less sodium fluoride than stated on the label. Affected lots were distributed nationwide.
Product
CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0453-2022·2022-02-02
CariFree CTx4 GEL 5000 Recalled for Subpotent Fluoride Content
CariFree CTx4 GEL 5000 (Lot 142017) contains less sodium fluoride than stated on the label. The product is being recalled and consumers should contact their healthcare provider with questions.
Product
CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 Distributed in 12-pk/cases
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0388-2022·2022-01-26
Drug Recall: Mucus Relief D Subpotent Tablets
Dr. Reddy's Laboratories is recalling Mucus Relief D (Guaifenesin Pseudoephedrine HCl ER Tablets) nationwide due to subpotency. The affected product was distributed to Walgreen Co. stores across the USA.
Product
Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, Made in India, NDC 0363-164-3
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0460-2022·2022-01-19
Sufentanil Citrate Injection Recalled for Subpotency
Akorn, Inc. is recalling Sufentanil Citrate Injection 100 mcg/2 mL due to subpotency—the drug was found to be out of specification for assay at the 30-month stability timepoint. Affected lot 031489A, with expiration 03/31/2022, was distributed nationwide.
Product
Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0294-2022·2021-12-29
Penicillin V Potassium Oral Solution recalled for subpotency
Teva Pharmaceuticals USA is recalling certain lots of Penicillin V Potassium for Oral Solution nationwide because the medication is subpotent—containing less active ingredient than labeled. The recall affects 100 mL and 200 mL bottles distributed nationwide.
Product
Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0233-2022·2021-11-24
Flocinolone Acetonide 0.01% Topical Oil Recalled for Subpotency
Amneal Pharmaceuticals is recalling Flocinolone Acetonide 0.01% Topical Oil due to an out-of-specification assay result indicating the drug is subpotent and may not deliver the intended therapeutic dose.
Product
Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0817-2021·2021-09-29
Sodium Sulfacetamide Wash Recalled for Subpotency Issues
Monarch PCM, LLC is recalling Sodium Sulfacetamide 10% Wash due to subpotency, meaning some bottles contain insufficient active ingredient or preservative levels.
Product
Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0818-2021·2021-09-29
Hydroquinone Skin Bleaching Cream Recalled for Subpotency Issues
Monarch PCM, LLC is recalling Hydroquinone 4% Skin Bleaching Cream due to subpotency affecting the active ingredient assay and preservative assay in one product each.
Product
HYDROQUINONE — HYDROQUINONE (HYDROQUINONE)
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0793-2021·2021-09-15
QiYu Hand Sanitizer 75% Ethyl Alcohol Recalled for Subpotency
Native Promotional Products is recalling QiYu Hand Sanitizer 500 mL bottles due to subpotency—the ethyl alcohol content does not meet the labeled 75% (v/v) specification. The voluntary recall affects products distributed to tribal nations in 13 states.
Product
QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by Native Promotional Products, Tulsa, OK NDC 74447-010
Category
Drug
Distribution
13 states
LowFDA (Drugs)·D-0784-2021·2021-09-08
Donepezil HCL Tablets 5 mg Recalled for Subpotency
Jubilant Cadista Pharmaceuticals is recalling Donepezil HCL Tablets, USP, 5 mg (Lot # DN120006A, exp. 12/2021) because the tablets are subpotent—meaning they contain less active ingredient than specified. The recall affects 14,544 bottles distributed nationwide.
Product
Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0763-2021·2021-09-01
PDI Povidone-Iodide Cleansing Scrub Swabstick Recall for Subpotency
Professional Disposables International is recalling PDI Povidone-Iodide Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning the active ingredient strength is below the required specification.
Product
PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0761-2021·2021-09-01
PDI Povidone-Iodine Swabstick Prep Pads Recalled for Subpotency
Professional Disposables International is recalling PDI Povidone-Iodine Swabsticks nationwide because the product is subpotent—meaning the active ingredient is below the required specification.
Product
PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0764-2021·2021-09-01
PDI Duo-Swab Povidone-Iodine Cleansing Swabstick Recalled for Subpotency
Professional Disposables International is recalling PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabsticks due to subpotency—the active ingredient is below the specified strength, which may reduce effectiveness for skin antisepsis.
Product
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)0
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0762-2021·2021-09-01
PDI Povidone-Iodine Cleansing Scrub Swabstick Recalled for Subpotency
Professional Disposables International is recalling PDI Povidone-Iodine Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning it contains less active ingredient than specified.
Product
PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0760-2021·2021-09-01
PVP Iodine Prep Pads Recalled for Potency Below Specification
Professional Disposables International is recalling PVP Iodine Prep Pads distributed nationwide because the product is subpotent—meaning the active ingredient strength falls below FDA specifications. Affected lots were distributed across the United States.
Product
PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0643-2021·2021-07-07
QiYu Hand Sanitizer Recalled for Subpotent Ethyl Alcohol Content
HoYu (US) Logistics Inc is recalling QiYu Hand Sanitizer (75% ethyl alcohol) because the product is subpotent. The recall affects 30,880 bottles distributed nationwide.
Product
QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by HoYu (US) Logistics Inc UPC 6 926645 716288
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0632-2021·2021-06-23
QiYu Hand Sanitizer Gel recalled for subpotency
World Source LLC is recalling QiYu Hand Sanitizer Gel (500 mL bottles) distributed to two hospitals in New York because the product is subpotent—meaning it contains less active ingredient than specified.
Product
QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui Cosmetics Co., Ltd., Baiyun District, Guanzhou
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0600-2021·2021-06-09
Micardis (Telmisartan) 80 mg Tablets Recall Due to Subpotency
Boehringer Ingelheim Pharmaceuticals is recalling Micardis 80 mg tablets (Lot #860412, expiration September 2022) because the tablets contain less active ingredient than required. This is a voluntary Class II recall.
Product
Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC 0597-0041-37), Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877
Category
Drug
Distribution
11 states
ModerateFDA (Drugs)·D-0391-2021·2021-05-26
Sun Pharma Recalls CEQUA Eye Drops for Subpotency and Particulates
Sun Pharmaceutical Industries is recalling CEQUA (cyclosporine) ophthalmic solution due to subpotent drug levels and the presence of particulates.
Product
CEQUA — CEQUA (CYCLOSPORINE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0240-2021·2021-02-03
IMC Wash-Free Hand Sanitizer Recalled for Methanol Contamination
Shane Erickson Inc is recalling IMC Wash-Free Hand Sanitizer because it was manufactured at a facility that produced subpotent products containing methanol.
Product
IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384. Labeled as a) SAFE-GUARD Products International, b) Safe-WAY JEVCO Wash-Free Hand Sanitizer, c) TRACTION CAPITAL, d) United State
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0239-2021·2021-02-03
IMC Wash-Free Hand Sanitizer Recalled for Methanol Contamination
Shane Erickson Inc is recalling IMC Wash-Free Hand Sanitizer because it was manufactured at a facility that produced subpotent product containing methanol.
Product
IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottles, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384, Made in China, ALSO distributed with Custom front labels as follows a) Sadie G. Mays Health & Rehabilitation Center, b) Pacers logo, c) no
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1601-2020·2020-09-23
RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations
RLC Labs Inc. is recalling Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The products were manufactured under conditions found to be subpotent.
Product
Nature-Throid, Thyroid USP [liothyronine (T3) 15.75 mcg and levothyroxine (T4) 66.5 mcg], 1.75 Grain (113.75 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3307-4; b) 60-count bottles, NDC 64727-3307-5; c) 90-count bottles, NDC 64727-3307-6; d) 100-count bottles, NDC 64
Category
Drug
Distribution
Distributed nationwide