Hazard

Stability Data Missing recalls

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

What the numbers show

Total: 12
Critical: 0
Severe: 1
Most recent: 2023-06-07

Of the 12 stability data missing recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (8%) 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 stability data missing 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.

1–12 of 12

ModerateFDA (Drugs)·D-0822-2023·2023-06-07
Lidocaine Ointment USP Recalled Due to Manufacturing Process Deviations
Akorn, Inc. recalls all lots of Lidocaine Ointment USP 5% (1 1/4 oz tubes) distributed nationwide due to CGMP deviations. The manufacturer could not complete required stability studies after closing operations.
Product
Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0697-2022·2022-03-30
Triamcinolone Acetonide Cream USP 0.1% Recall — Stability Study Discontinuation
Teligent Pharma is recalling all unexpired Triamcinolone Acetonide Cream USP 0.1% nationwide due to discontinuation of its stability study program, which creates a cGMP deviation. The company has recalled approximately 721,225 tubes and 90,893 jars distributed across multiple package sizes.
Product
Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 grams tubes, NDC 52565-056-30; c) 80 grams tubes, NDC 52565-056-80, d) 1 lb (454 g) jars, NDC 52565-056-26; Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0537-2018·2018-02-28
FDA Recalls Methylcobalamin Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Methylcobalamin (Vitamin B12) for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.
Product
Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8056-2); c) 5g (NDC 58597-8056-3); d) 10g (NDC 58597-8056-4), e) 25 g (NDC 58597-8056-4); f) 100g (NDC 58597-8056-6), RX only, packed by American Pharmaceutical I
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0493-2018·2018-02-28
Flurbiprofen USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients is recalling Flurbiprofen USP for prescription compounding because it lacks stability data to support expiration dates.
Product
Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)100g (NDC 58597-8075-6) ; c) 500g (NDC 58597-8075-7); d) 1000g (NDC 58597-8075-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0492-2018·2018-02-28
Fluconazole USP Recalled for Lack of Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Fluconazole USP for prescription compounding due to CGMP deviations involving missing stability data and controls.
Product
Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0526-2018·2018-02-28
FDA Recalls Testosterone Cypionate Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Testosterone Cypionate USP for prescription compounding because the manufacturer lacks stability data to support the assigned expiration dates.
Product
Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g (NDC 58597-0078-6); b) 500g (NDC 58597-0078-7); c) 1000g (NDC 58597-0078-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0518-2018·2018-02-28
Progesterone USP Recalled for Lack of Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Progesterone USP for prescription compounding due to CGMP deviations involving missing stability data and controls.
Product
Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25g (NDC 58597-8471-4); d) 100g (NDC 58597-8471-6); e) 500g (NDC 58597-8471-7); f) 1000g (NDC 58597-8471-8); g) 5000g (NDC 58597-8471-9), RX only
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0515-2018·2018-02-28
Pentoxifylline USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Pentoxifylline USP for prescription compounding because it lacks stability data to support its expiration date.
Product
Pentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 58597-8429-4); b) 100g (NDC 58597-8429-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0519-2018·2018-02-28
Sildenafil Citrate USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Sildenafil Citrate USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.
Product
Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c) 50g (NDC 58597-8088-5); d) 100g (NDC 58597-8088-6); e) 500g (NDC 58597-8088-7); f)1000g (NDC 58597-8088-8), RX only, packed by American Pharmaceutical Ingredien
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0495-2018·2018-02-28
FDA Recalls Hydroxyprogesterone Caproate Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Hydroxyprogesterone Caproate USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.
Product
Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a) 25g (NDC 58597-8051-4); b) 100g (NDC 58597-8051-6); c) 500g (NDC 58597-8051-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-844-2015·2015-04-29
Attix Pharmaceuticals Recalls Piperacillin Sodium Due to Missing Stability Data
Attix Pharmaceuticals is recalling Piperacillin Sodium active pharmaceutical ingredient because it was repackaged without data supporting the printed expiry date.
Product
Piperacillin Sodium active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-520-2015·2015-04-29
Attix Pharmaceuticals Recalls Amoxicillin Trihydrate Due to Missing Stability Data
Attix Pharmaceuticals is recalling Amoxicillin Trihydrate active pharmaceutical ingredient because stability data does not support the printed expiry dates.
Product
Amoxicillin Trihydrate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Drug
Distribution
Distributed nationwide