Hazard

Out Of Specification recalls

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

About this hazard tag

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

176–184 of 184

ModerateFDA (Drugs)·D-0873-2021·2021-10-06
Washington Homeopathic Products Althaea 6X Bladder Pills Recalled
Washington Homeopathic Products is recalling Althaea 6X Irritable Bladder Pills due to out-of-specification test results from identification testing. Ten bottles nationwide have been affected.
Product
Althaea 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 1 OZ, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0874-2021·2021-10-06
Althaea 6X Irritable Bladder Homeopathic Drops Recalled for Failed Identification Testing
Washington Homeopathic Products is recalling Althaea 6X Irritable Bladder drops (Lot #29377) distributed nationwide because identification testing via HPTLC analysis produced out-of-specification results.
Product
Althaea 6X, Iritable Bladder* 20% Alcohol, Drops, packaged as 15 ml, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0895-2021·2021-10-06
Washington Homeopathic Products Aconitum Napellus 12X Fear Recall
Washington Homeopathic Products is recalling Aconitum Napellus 12X Fear homeopathic medicine due to out-of-specification test results from identification testing.
Product
Aconitum Napellus 12X Fear* 87% Alcohol HPUS: packaged in 30 mL containers; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0802-2021·2021-09-22
Betamethasone Dipropionate Lotion recalled for unknown impurity
Akorn, Inc. is recalling Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, due to an unknown impurity found in the product that exceeds specification limits. The affected lots were distributed nationwide.
Product
Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701
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-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-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
LowFDA (Drugs)·D-0655-2021·2021-07-21
LEUKINE (Sargramostim) Injection Recalled for Failed Stability Specification
Partner Therapeutics Inc is recalling LEUKINE (sargramostim) for injection due to an out-of-specification result observed at the 27-month stability timepoint. The recall affects 32,260 vials distributed to one government account.
Product
LEUKINE — LEUKINE (SARGRAMOSTIM)
Category
Drug
Distribution
0 states