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.

226–250 of 405

  • LowFDA (Drugs)·D-0110-2018·2017-12-27

    Osmotica Recalls Subpotent Methylphenidate Hydrochloride Extended-Release Tablets

    Osmotica Pharmaceutical Corp is voluntarily recalling 10,064 bottles of subpotent Methylphenidate Hydrochloride Extended-Release Tablets nationwide.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0081-2018·2017-11-22

    Llorens Pharmaceutical Recalls Urin D/S Tablets Due to Potency Issues

    Llorens Pharmaceutical Corp. is recalling Urin D/S Tablets because FDA analysis found the product to be out of specification for assay, resulting in subpotent or superpotent tablets.

    Product
    Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, Rx Only, 100-count bottle, Manufactured For: Llorens Pharmaceutical Corp., International Division, Miami, FL 33166. NDC: 54859-701-10
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0057-2018·2017-11-08

    Precision Dose Recalls Subpotent Carbamazepine Oral Suspension Unit Dose Cups

    Precision Dose Inc. is recalling Carbamazepine Oral Suspension USP unit dose cups because they tested below the required potency specifications.

    Product
    Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0048-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 90 bags of compounded Oxytocin 40 units in Lactated Ringer's because the drug was subpotent.

    Product
    Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-245-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0047-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 24,486 bags of compounded Oxytocin 30 units in Lactated Ringer's because the drug was subpotent.

    Product
    Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-243-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0035-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 564 bags of compounded Oxytocin 10 units in Lactated Ringer's Injection because the drug was subpotent.

    Product
    Oxytocin 10 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-237-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0041-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 60 bags of compounded Oxytocin injection because the drug was found to be subpotent.

    Product
    Oxytocin 20 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0049-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide

    Pharmedium Services is voluntarily recalling 42 bags of compounded Oxytocin 40 units in Lactated Ringer's solution because the drug was subpotent.

    Product
    Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-245-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0042-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 534 bags of compounded Oxytocin 30 units in 1000 mL bags because the drug was found to be subpotent.

    Product
    Oxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-242-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0044-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide

    Pharmedium Services is recalling 6,108 bags of compounded Oxytocin 30 units in Lactated Ringer's because the drug was subpotent. The recall is voluntary and nationwide.

    Product
    Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-243-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0036-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide

    Pharmedium Services, LLC is recalling 1,308 bags of compounded Oxytocin 10 units in Lactated Ringer's Injection because the drug was subpotent.

    Product
    Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag ,Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-237-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0043-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 4,452 bags of compounded Oxytocin 30 units due to subpotent drug levels. The FDA classified this as a Class II recall.

    Product
    Oxytocin 30 units added to 500 mL 5% Dextrose/Lactated Ringer's USP in 500 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-242-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0045-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 763 bags of compounded Oxytocin 30 units in Lactated Ringer's USP. The recall was initiated because the drug was found to be subpotent.

    Product
    Oxytocin 30 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-243-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0038-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling Oxytocin 20 units in Lactated Ringer's Injection USP bags because the drug was found to be subpotent.

    Product
    Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0037-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 2,232 bags of compounded Oxytocin injection because the drug was found to be subpotent.

    Product
    Oxytocin 15 units added to 250 mL Lactated Ringer's Injection USP in 250 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-239-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0040-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Lactated Ringer's Injection Bags

    Pharmedium Services, LLC is voluntarily recalling 978 bags of compounded Oxytocin in Lactated Ringer's Injection because the drug was subpotent.

    Product
    Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0046-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 1,152 bags of compounded Oxytocin 40 units in Lactated Ringer's USP because the drug was subpotent.

    Product
    Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-245-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0039-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 390 bags of compounded Oxytocin 20 units in Lactated Ringer's Injection due to subpotent drug levels.

    Product
    Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1108-2017·2017-08-23

    Linde Eckstein Recalls SPF 10 Liquid Make-Up Due to Subpotent Drug

    Linde Eckstein is recalling specific lots of Make Up Perfect sand SPF 10 liquid make-up because the SPF 10 protection claim cannot be fully guaranteed.

    Product
    Make Up Perfect sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03320, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033200.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1104-2017·2017-08-23

    Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Drug Concerns

    Linde Eckstein is recalling specific lots of SPF 10 liquid make-up because the sun protection claim cannot be fully guaranteed.

    Product
    Make Up Transparent dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03240, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032401.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1090-2017·2017-08-23

    Akorn Recalls Halyard Chlorhexidine Oral Rinse Due to Crystallization

    Akorn Inc is recalling Halyard 24-Hour Oral Care Kits containing chlorhexidine gluconate oral rinse due to crystallization and subpotent assay results.

    Product
    Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1102-2017·2017-08-23

    Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Drug Claim

    Linde Eckstein is recalling specific lots of SPF 10 liquid make-up because the sun protection factor claim cannot be fully guaranteed.

    Product
    Make Up Transparent sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03220, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032203.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1109-2017·2017-08-23

    Linde Eckstein Recalls Make Up Perfect SPF 10 Liquid Make-up

    Linde Eckstein Gmbh + Co KG is recalling Make Up Perfect dark tan SPF 10 liquid make-up because the SPF 10 protection claim cannot be guaranteed.

    Product
    Make Up Perfect dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03340, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033408.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1107-2017·2017-08-23

    Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Sun Protection

    Linde Eckstein is recalling SPF 10 liquid make-up because the sun protection claim cannot be fully guaranteed. Consumers should stop using the product.

    Product
    Make Up Perfect pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03310, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033101.
    Category
    Drug
    Distribution
    0 states